1. SOME CHEMICAL COMPOSITION OF SEABUCKTHORN WASTE RESIDUE
Khorolsuren U. ; Badamtsetseg S.
Mongolian Pharmacy and Pharmacology 2013;2(1):20-
Introduction: In last years, many farmers, manufacturers and reserchers have paid attention to the seabuckthorn cultivation, production and investigation due to seabuckthorn berry’s value and possitive effect on human body. As is known, the fruits of seabuckthorn are used for the production of oil and juice [1,2] in Mongolia. Thereby, the large volume of waste residue material from seabuckthorn, such as pulp, skin and seed residues from juice and oil extraction, could be developed into a biologically activity product.We studied some chemical composition of seabuckthorn waste residue. Waste residue was sampled from Monos Food Co.,Ltd. Moisture content was determined by gravimetric method, the ash content was determined by incinerating in a muffle furnance at 5500C, vitamin C and total carotinoidwere determined by method of Mongolian National Pharmacopeia [3]. Moisture was 71.65%, total mineral element (ash) was 4%, acidity was 0.26%, Vitamin C was 0.03 mg% and total carotinoid was 0.02 mg%. Our next study will utilize seabuckthorn waste to develop bioactive product and food additive.References:1. Janick J and Whipkey A. “Product development of sea buckthorn“ ASHS Press, Alexandria, VA 2002. p. 393–398.2. Dychko K. A., Kulagina E. V. “Chemical composition and pharmacological activity of an aqueous extract from sea buckthorn waste products” Pharmaceutical Chemistry Journal. Vol 32. No 4. 1998. P.32-34.3. Mongolian Pharmacopeia 2011, 372
2.Fatty acid composition of sea-buckthorn (Hippophae rhamnodes L. ) oil
Badamtsetseg S ; Bayanmunkh A ; Lkhagva L ; Khurelbaatar L
Mongolian Medical Sciences 2014;169(3):47-50
IntroductionSea buckthorn is known to be one of the vitamin-rich berries in the plant kingdom and has beencredentialed as highly valued for healthy living, improving well-being, enhancing lifestyle, and preventingthe disease. Widely recognized in Northern regions of Europe and Asia, Hippophae rhamnodes hasbeen used medicinally for thousands of years. Both of seed and pulp oil have tocopherols, carotinoids,as well as ω-3 and ω-6 fatty acid families. The seed oil is highly unsaturated, with proportions of linoleic(C 18:2n-6) and α-linolenic (C18:3n-3) acids between 30-40% and 20-35%, respectively, whereas thepulp oil is more saturated containing high amounts of palmitoleic (C16:1n-7, 16-54%) and palmitic acids(16:0,17-47%). Many researchers including Laagan B., Avdai Ch., Tsendeekhuu Ts., Vernik S. R.,Jamyansan Y., Badamkhand D., Odonmajig P have determined content of berry, fatty acid compositionof sea buckthorn pulp and seed oil since 1970 in Mongolia. However, total fat and fatty acids compositionof Hippophae rhamnodes general is known, limited reports exist dealing with comparative differencesin fatty acid composition of Hippophae rhamnodes grown in Mongolia. Therefore, we analyzed thecomposition of fatty acids pulp oil and seed oil in sea buckthorn grown in Mongolia.Materials and MethodsPulp and seed oil were produced in Monos Food Co Ltd., and fatty acid methyl ester were analyzedusing Agilent Packard Gas Chromatograph (GC) (Model HP-6890 Agilent Packard) with mass-spectrumdetector (Model HP MSD 5973N).ResultThe results indicated that unsaturated fatty acids in the seed oil (85.4%) and in pulp oil (62.5%) arehigher than saturated fatty acids of seed oil (14.6%) and pulp oil (37.1%) respectively. The mostimportant factor defining the nutritional value of oil is ratio of unsaturated fatty acids present in oil. Theseed oil contains palmitic acid (10.8%), oleic acid (20.3%), limoleic acid (42.9%), α-linolenic acid (5.6%),Eicosadienoic acid (14.7%). Pulp oil of Hippophae rhamnodes has palmitic acid (35.4%), palmitoleicacid (38.5%), oleic acid (including Vaccenic acid) (6.6%) and linoleic acid (10.4%). The palmitic acid andpalmitoleic acid ratio in pulp oil was more than in seed oil. While oleic acid, linoleic acid and α-linolenicacid in seed oil have a higher ratio than that of pulp oil. It shows that unsaturated fatty acids in seed oilare much higher than pulp oil.ConclusionUnsaturated fatty acids in the pulp oil contain 62.5%, including essential fatty acid ω-3, 6, 9 (18.2%);it is content of 29.12% in unsaturated fatty acids. While, unsaturated fatty acids of seed oil contains85.4% in total fatty acid and essential fatty acid contains 96.72% in unsaturated fatty acid. It can thus beconcluded that seed oil is better than pulp oil because the former contains essential fatty acid.
3. PHARMACOLOGICAL EFFECTS OF SILLICHOL ON BILE SECRETION AND
Davaasambuu Ò ; Badamtsetseg S ; Oyunchimeg B ; Lkhagvasuren ; Sosorburam B ; Chimgee TS
Mongolian Pharmacy and Pharmacology 2015;7(2):81-81
Varieties of plants and lyophilized bovine bile have been used for increase secretion of bile in traditional systems of medicine of various countries. Following many articles note on the benefi cial effects of lyophilized bovine bile particularly on the wound healing and gastric protection effects, there is paucity of reports in literature on its effects on a bile secretion, a bile bilirubin, bile cholesterol and a plasma cholesterol levels. Sillichol contains lyophilizedbovine bile, liver hydrolisate, yarrow extract and silymarin. The aim of this study was to find out the effect of bile fl ow, bile bilirubin concentration bile cholesterol level and hepatoprotective of Sillichol. Sixteen adult male wistar rats (weighing between 200-250 gr) were used in the study. They were randomly assigned into control and sillichol group comprising 4 in each group. Thereafter, they were weighed and anaesthetized with ketamine (2ml/200gr body weight) muscle leg and quickly pinned to a dissecting board. Laparotomy was performed and liver lobes were defl ected anterolaterally to expose the common bile duct. The common bile duct was cannulated with a portex cannula (0.5 mm diameter) after a semitransection was made on the bile duct. The cannuls was held in place with thread tied over it and around the bile duct.The bile was collected for 8 hours from each rat studied according to method of Rozuet Jousse. The rate of bile fl ow was noted, the volume of bilirubin, bile cholesterol levels were determined in the control and test groups. Moreover, total of 18 wistar rats (200-250 gr) were obtainedfrom laboratory house of Drug research institute and acclimated for 10 days before starting the experiment. Liver toxicity was induced by the subcutaneous injection of carbon tetrachloride (CCL4, 0.4 ml/100gr), 1:1 diluted with paraffi n oil, for four successive days of the experiment (N.P.Scakun et al, 1983). The rats were divided randomly into 3 groups comprising 6 rats in each group and fed the same diet throughout the experimental period. Mean values of bile cholesterol and bilirubinlevels, rate of bile secretion in the control and sillichol group. Bile cholesterol levels were signifi cantly decreased in the sillichol group compared with the control group (60.3±0.88 mg/dl vs 62.6±1.21mg/dl, p<0.05). Rate of bile secretion was signifi cantly increased in the experimental compared with the control group(10.21±0.25 ml/8hr vs 4.18±0.25 ml/8hr, p<0.05). Total bilirubin, conjugated and unconjugatedbilirubin concentrations in both sillichol and control groups were not signifi cantly different (p<0.01). The activities of GOT, GPT and ALP were estimated in serum samples as the liver function biomarkers using biochemical diagnostic test. The CCL4 treatment markedly affected the liverspecifi c enzymes. It was found that a signifi cant (p<0.05) increase in serum GOT, GPT and ALP activities of CCL4 treated rats. After the treats, hepatic biomarkers were elevated in the serum due to release of the enzymes from damaged liver. GOT (69.8±1.5), GPT (103.9±1.2), ALP (23.8±0.2) and Cholesterol (67.7±13.6) andtriglyceride (64.0±3.3) levels weredecreasedsignifi cantly (p<0.05) in the sillichol groupcompared with the control group. Silichol is decreasing concentration of cholesterol and bilirubin’s level in bile, constantly after administration of drug. Also, liverpreparation is increasing bile acid secretion in hepatocytes and a speed of secretion.From the results of pharmacological study concluded that involves CCL4 induced acute toxic hepatitis, liver preparation has hepatoprotective effect by protecting the liver cells from injury, improving the regeneration process and by correcting metabolic functions of the liver.
4.Results of determination Ginsenoside of Panax ginseng cultivated in Mongolia
Chuluuntsetseg J ; Badamtsetseg S ; Bayanmunkh A ; Khurelbaatar L ; Lkhagva L ; Bud J
Mongolian Medical Sciences 2016;176(2):60-64
BackgroundPanax ginseng is one of the most important medicinal plants in Asia. Triterpene saponins(ginsenosides) are the main bioactive compounds in P.ginseng. The present study investigated thegrowth characteristics of ginsenoside content in the leaves and roots of Panax ginseng at differentgrowth stages (from 1 and 4 years). Analysis was P.ginseng leaves and roots indicated the presenceof two ginsenosides (Rg1 and Rb1) content of Rg1 was higher than Rb1.Aim: The main aim of this study was determine by high performance liquid chromatography (HPLC)ginsenoside Rg1 an Rb1 of P.ginseng grown in Mongolia.Materials and MethodsLeaves and roots of different ages of P.ginseng were collected at October of 2015 in field of Umnugoviprovince, Mongolia. Collected samples were dried and powdered. Samples were extracted with70% EtOH, water saturated butanol and methanol. The extract was filtrated through filter paper(whatman No.42) and evaporated vacuum rotor. The evaporated extract was resuspended with theMethanol. It stored in room temperature and resuspended mobile phase use for HPLC analysis.The two ginsenosides were analyzed using HPLC system of a model (DGU-20A3r Shimadzu) andcolumn was Octadecylsilane 5μm I-150mm, D-4.6mm, detector was UV 204 nm. The sample wasinjected (20μl) and applied gradient elution was as follows British pharmacopeia.ResultsGinsenosides levels were much higher in the 4 ages roots compared with the 1 ages roots.Ginsenoside amounts in P.ginseng organs changed depending on the specific time during thevegetation season the samples were taken. This study found that the highest content of thesemetabolites-2.082% (butanol extract) occurred in the roots. Our study was independently of thevegetation season. These were Rb1 and Rg1, with values Rg1 was 0.7-2.082% and Rb1 was 0.002-0.03%.ConclusionGinsenosides are generally distributed throughout all the parts of the ginseng plant. We found thatthe highest Ginsenoside Rg1 content accumulated during the first year of growth then decreaseduntil four year.
5.Chemical analysis of animal and plants origin raw materials to improve body potential and strength
Battulga B ; Badamtsetseg S ; Oyunchimeg B ; Battulga G ; Khurelbaatar L
Mongolian Medical Sciences 2014;169(3):51-54
IntroductionOur country imported drugs that are contain androgen and testosterone with high selling cost. Therefore,we have to made new body potential and strength biologically activity product which have natural, lowcost and high effective.GoalThe main purpose of study was to determine chemical composition of dried testicle powder and maincompounds of Tribulus terrestris, Astragalus mongolicus.Material and MethodsThe bovine testicle used in this research was purchased from “Makh Market” Co.Ltd in 2013. T.terrestriswas collected from Gurvansaikhan, Dundgobi province July 20, 2014 and A. mongolicus was collectedfrom Botanical garden of Medicinal Plant of Drug Research Institute in September, 2014. Testicles wereremoved from skin and other parts than cut in a mechanical cutting machine. It was freeze dried at -500Cby Labconco freezone12 freeze drier. 500 g of the finely powdered T. terrestris was extracted three timeswith 5000 ml 70% ethanol for 72 hours. All extracts were combined and evaporated by vacuum rotary till2500 ml. 50 g of the powdered A. mongolicus was extracted three times with 500 ml of distilled water for72 hours. Extract was heated until 800C for 24 hours. Extract were collected and evaporated by vacuumrotary till 200 ml. Protodioscin was determined by high performance liquid chromatography (HPLC) wasachieved by using reversed-phase (RP-18) column, ultraviolet detector (UV) and water, acetonitrilegradient as mobile phase, polysaccharide was determined spectrophotometric method, protein wasanalyzed by Kjeldahl method, moisture was measured by Moisture balance 6KD-50K instrument, totalfat was analyzed by Soxhlet apparatus.ResultThe analyses of testicle powder showed 69.8% protein, 8.0% ashes, 5.42% moisture, 15.6% total fatcontent and protodioscin content 1.12% in T.terrestris extract. In A.mongolicus water extract the 7.26%polysaccharide content was found. We were determined to chemical composition of bovine testiclepowder and results were agreed with MNS 5775:2007. More over, high content of polysaccharide andprotodioscin were found T.terrestris and A.mongolicus. Therefore, those raw materials can use forpotential and strength biological activity product.
6.Comparative study of fatty acid composition of anti-cancer Ellipin preparation at the production stage
Badamtsetseg S ; Bayanmunkh A ; Uuganbayar M ; Battulga B ; Radnaeva L D ; Lkhagva L ; Khurelbaatar L
Mongolian Medical Sciences 2014;170(4):73-77
Introduction. Monos Group, Drug Research Institute is starting to investigate of Ellipin preparationfrom the mid-1990s, Ellipin has anti cancer activity in liver and several studies were investigated withscientists from Japan and China. Especially Hayashi K., Khurelbaatar L and Ambaga M were determinedanti-cancer action of the preparation and they were explained of mechanism of action, which apoptosisis seduced by influence of unsaturated fatty acids in tumor cells. However, changes of fatty acidscomposition at production stage were did not study yet. Therefore, we studied that composition of fattyacids in different term of production stage and compared of Ellipin dense substance.Materials and Methods. Samples of study were collected from production stage of “Ellipin” series130304, which was tacked in 48th hour, 120th hour of production. Each sample was dried at freezedryer “Labconco freezone12L” in Drug Research Institute. Total lipids of sample were extracted withchloroform: methanol (2: 1 v/v) according to Folch et al. Fatty acid methyl esters were analyzed usingAgilent Packard Gas Chromatograph (GC) (Model HP-6890 Agilent Packard) with mass-spectrumdetector (Model HP MSD 5973N) of Buryat State University, in Ulan-Ude.Results. Ellipin preparation is derived from bovine liver, and which is based on homogenization of bovineliver for isotonic. In this process, unsaturated fatty acids were extracted in organic solution. We studiedchanges which saturated and unsaturated fatty acids of bovine liver in process of homogenization andconsist of each fatty acid contents of end product. Results have shown that unsaturated fatty acidswere decreased by 0.4-44% till 120th hour of homogenization process. While, there were decreasedby 4-12% in the end product, although, ω-6 fatty acids were increased by 13.1-38.4%. Moreover, 25saturated fatty acids and 12 unsaturated fatty acids were detected in the Ellipin dense substance (endproduct). Hence, 67.5% of total fatty acid was saturated fatty acids, 32.5% was unsaturated fatty acidsin the Ellipin dense substance. Resent results and results of previous studies indicated that Ellipindense substance may contains saturated fatty acids on in average 50.34%, unsaturated fatty acids onin average 49,32%, respectively.Conclusion. Proportion of saturated and unsaturated fatty acids in Ellipin production was about 2:1.Saturated fatty acids and unsaturated fatty acids were found 25 and 12, respectively. Saturated fattyacids were gradually decreased and unsaturated fatty acids were slowly increased in production period,which from 48th hour of production-conveyer till end product. Moreover, content of ω-3-6-9 fatty acidswas consist 83,9-87,5% of total unsaturated fatty acid.
7.Investigation of bile secretion and hepatoprotective effects of “Sillichol” biological active product
Badamtsetseg S ; Davaasambuu T ; Oyunchimeg B ; Battulga B ; Odchimeg B ; Sosorburam B ; Chimgee TS ; Ariunsaikhan TS ; Lkhagva L ; Hurelbaatar L
Mongolian Medical Sciences 2016;176(2):52-59
AbstractIntroduction: In recent years, researchers have paid attention to the biological active products fromraw materials of animal origin. Lyophilized bovine bile and bovine liver hydrolyze and varieties ofplants have been used for increase secretion of bile in traditional systems of medicine of variouscountries. We investigated that beneficial effects of new product particularly its treatment liverdamage, improve regeneration process of damaged liver cell, effects on bile secretion, bile bilirubin,and bile cholesterol and plasma cholesterol levels. Moreover, we investigate physical, chemicalcapacity and drafted a MNS document.Goal: To complete pharmacological, technological and standardization study of Sillichol biologicalactive product.Material and MethodsSeveral biochemical methods were used for determination of chemical compounds in liverhydrolysate and lyophilized bile. The product was formed in combined powder form by dried stirringmethod and it was capsuled by NJP-1200 capsule machine. Litchfield-Wilcoxon’s method was usedto study the acute toxicity effect. The median lethal dose (LD50) value was calculated using themethod of Pearson and toxicity level of was determined according to classification of Sidorov K.K(1973). Human equivalent dose (effective dose) was calculated with according to FDA guidancefor drug-dose conversion. Acute hepatitis – Carbon tetrachloride (CCl4) induced liver damage inrats (Skakun et al, 1984); Bile secretion effect was determined by method of Rozuet Jousse, 1980.All value expressed as mean S.E obtained from n number of experiments. The Student’s t-testfor unpaired observation between control and experimental samples was carried out for statisticalevaluation of a difference; p values of 0.05 or less were considered as statistically significant.ResultsTotal nitrogen, amino nitrogen, fat, ash and solution index were measured in liver hydrolysate.The results were accepted standard requirements of MNS 6484:2014. Bovine bile was dried byLabconco freezone L12 freeze drier in Drug Research Institute. The product named Sillichol wasformed combined powder form and capsuled №0 capsule. From the result of preclinical study, ourinvestigational new product is included in practically non-toxic class according to toxicity classificationby Sidorov (1750 mg/kg). Sillichol biological active product was increase bile level which is producedin liver cells and decreased bile cholesterol levels by 2.3-8.0% in the test group compared with thecontrol and reference groups.Conclusion: The biological active product was improving regeneration process of liver cells,normalize cell structure, effect to the anti-inflammatory in damaged liver cells.
8.Method Validation of Dihydromyricetin in Anti-hangover preparation by High Performance Liquid Chromatography
Battulga B ; Badamtsetseg S ; Bayanmunkh A ; Tsetsegmaa S ; Lkhagva L ; Khurelbaatar L
Mongolian Medical Sciences 2019;189(3):54-61
Background:
The high performance liquid chromatography (HPLC) method was developed for selective determination
of dihydromyricetin in capsule formulation dietary supplement containing other components. Further, the
proposed method was validated for linearity, precision (system precision, method precision, intermediate
or inter-day precision), and accuracy, stability in analytical solution, system suitability and ruggedness.
The developed method exhibited the best results in terms of the aforesaid validation parameters. The
other components and additives did not interfere in their determinations. The method was found to be
selective, simple, economical, accurate, reproducible, rapid and reliable for routine estimation purpose of
dihydromyricetin in dietary supplement capsule.
Goal :
The goal of this study was to develop the validation method of dihydromyricetin in the dietary supplement.
Material and Methods :
The hangover preparation was produced by Technological section of Drug Research Institute. The
standard dihydromyricetin was supplied from Sigma Aldrich Co. We used solvents for HPLC grade
(methanol, acetonitrile). Chromatographic conditions: A gradient HPLC (Shimadzu LC20AD) with serial
dual plunger pump; analytical column: Supelco inertsil С18 250 × 4.6 mm, particle size 5 μm; flow rate: 1
ml/min; column temperature: 350C, detection: UV 365 nm. Chromatographic procedure: 20 μl of the mixed standard preparation and assay (sample) preparation were separately injected into the chromatography, the chromatograms were recorded, and the responses for the major peaks were measured. The run time
was approximately 10 minutes.
Results
The calibration curves for dihydromyricetin were made by plotting the peak area versus the concentration for each analyte using regression analysis. Each calibration curve was obtained using six levels of concentrations in the range 28-224 µg/mL. The linear correlation coefficient (r2 ) for all calibration curves was higher than 0.999 for all analytes. The LOD and LOQ for dihydromyricetin were in 11.29 µg/mL and 34.21 µg/mL, respectively. Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low, middle and high concentrations. The RSD values of both repeatability and intermediate precision were below 0.261% and 0.262%. The accuracy remaining between 101.65 to 104.7%. The resulting accuracy data were satisfactory for the quantitative analysis of dihydromyricetin in anti-hangover preparation. The results of summarized in Table 1, 2, 3. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method for qualitative and quantitative analysis of dihydromyricetin, as part of the quality assessment of products containing anti-hangover preparation.
9.High performance liquid chromatograohy method for determination of alkaloid, method validation in Norbu-7 granule
Sugarmaa B ; Battulga B ; Lkhaasuren R ; Badamtsetseg S ; Tsetsegmaa S ; Khurelbaatar L
Mongolian Medical Sciences 2021;195(1):64-69
Introduction :
The roots of Sophora Flavescentis is one of the key ingredient in Norbu 7 traditional medicine, the
bioactive compound being quinolizidine alkaloids, matrine and oxymatrine. A high performance liquid
chromatography (HPLC) method was used to determine matrine, oxymatrine simultaneously in the
traditional medicine. The HPLC method was tested and validated for selective determination of matrine
and oxymatrine in the Norbu 7 granule. The proposed method was validated for linearity, precision
(system precision, method precision, intermediate or inter- day precision) and accuracy, stability in
analytical solution, system suitability and ruggedness.
Goal:
The goal of this study was to develop validated determination method of alkaloid in Norbu 7 granule
for quality control.
Material and Method:
HPLC analysis was performed on Chromecore amino bonded silica gel as the stationary phase (250
mm : 4.6 mm i.d., 5µm) using mixture of acetonitrile, dehydrated ethanol and 3% phosphoric acid
(80:10:10) as the mobile phase, 220 nm as the UV light detection.
The research methodology was approved by Research Ethic Review Committee of Mongolian
University of Pharmaceutical Science on 16th of November, 2020.
Results:
The calibration curve of oxymatrine showed good linearity (R2=0.9955) within the established range
of 8 – 64 µg/ml. The limit of detection (LOD) and quantification (LOQ) were 10.13 µg/ml and 30.71 µg/
ml respectively. Good results were achieved with repeatability (%RSD < 2.0) and recovery (93.08 –
104.32%).
Conclusion
The method was found to be selective, accurate, reproducible and the other components did not
interfere with determinations. It was successfully used to analyze the granule traditional medicine with
7 different plant formulation and additives. The HPLC method can be used to evaluate and control
quality, stability of Norbu 7 granules.
10.Method validation of pyridoxine hydrochloride in neurorubin by high performance liquid chromatography
Khaiunsarnai Ts ; Battulga B ; Badamtsetseg S ; Bayanmunkh A ; Tsetsegmaa S ; Lkhagva L ; Khurelbaatar L
Mongolian Pharmacy and Pharmacology 2020;16(1):6-12
Introduction:
Pyridoxine hydrochloride is least expensive supplement named as a vitamin 61. Pyridoxal kinase is the enzyme that produces pyridoxal phosphate which known as pyridoxine hydrochloride that occurs in the human body. Diabetes, age and neurodegenerative diseases complications can be reduced by pyridoxine hydrochloride2 3. Quantification of pyridoxine hydrochloride in neurorubin as an injection form was developed by high performance liquid chromatography (HPLC) method.
Further, the proposed method was validated for linearity, precision (system precision, method precision, intermediate or inter-day precision), and accuracy, stability in analytical solution, system suitability and roughness. The developed method exhibited the best results in terms of the aforesaid validation parameters. The method was found to be selective, simple, economical, accurate, reproducible, rapid and reliable for routine estimation purpose of pyridoxine hydrochloride in injection.
Goal:
The aim of this study was to develop the validation method of pyridoxine hydrochloride in injection.
Material and Methods:
I) Test Article. As a test article neurorubin injection was produced by Tsombo Farm LLC. The standard pyridoxine hydrochloride was supplied from Sigma Aldrich Co.
II) Reagents and Equipment. The reagents were HPLC grade acetonitrile methanol, and purified water. Balance, and micropipette used as equipment. Shimadzu HPLC (LC20AD) was used as the analytical instrument and the analysis conditions were as follows (Table 1).
Results
The calibration curves for pyridoxine hydrochloride were made by plotting the peak area versus the concentration for each analyte using regression analysis. Each calibration curve was obtained using six levels of concentrations in the range 12.5-100 pg/mL. The linear correlation coefficient (R2) for all calibration curves was higher than 0.995 for all analytes. The LOD and LOQ for pyridoxine hydrochloride were in 15.29 pg/mL and 46.33 pg/mL, respectively.
Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low, middle and high concentrations. The RSD values of both repeatability and intermediate precision were below 1.669 % and 1.678 % the accuracy remaining between 95.25 to 102.775 %. The resulting accuracy data were satisfactory for the quantitative analysis of pyridoxine hydrochloride in neurorubin injection.
The results of summarized in table 2, 3, 4. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method for qualitative and quantitative analysis of pyridoxine hydrochloride, as part of the quality assessment of products containing in injection.