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Simultaneous Determination of Two Ingredients in Indometacin and Furazolidone Suppositories by HPLC

Liqiong WANG ; Changyong WEI ; Xiaoyan WU ; Yilin FANG

China Pharmacist.2017;20(5):961-963.

Objective: To establish an HPLC method for the simultaneous determination of two ingredients in indometacin and furazolidone suppositories.Methods: The analysis was performed on an XTerra(R) RP18 column (250 mm×4.6 mm, 5 μm) with gradient elution of methanol and 0.01 mol·L-1 potassium dihydrogen phosphate-triethylamine (100∶0.02) at the flow rate of 1.0 ml·min-1.The column temperature was 30 ℃ and the detection wavelength was 263 nm.The injection volume was 10 μl.Results: The peaks of furazolidone and indometacin were successfully separated.The linear range of calibration curves was 5.12-81.87 μg·ml-1 (r =1.0000) and 3.78-60.45 μg·ml-1 (r =1.0000), respectively.The average recovey was 99.6% (RSD =1.5%, n =6) and 100.3% (RSD =1.6%, n =6), respectively.The limit of quantification (LOQ) was 0.02 μg·ml-1 and 0.05 μg·ml-1, respectively.Conclusion: The established method is validated to be suitable for the quality control of indometacin and furazolidone suppositories.

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Content Comparison of Saikosaponin a, d and Total Flavonoids in Different Parts of Hollow Bupleurumin

Xiaoyan ZHANG ; Mengfei XU ; Yu ZHU ; Hui XIONG ; Fang LIU

China Pharmacist.2017;20(5):958-960.

Objective: To compare the contents of saikosaponin a, d and total flavonoids in different parts of Hollow bupleurum to provide reference for the clinical use of medicinal parts.Methods: The determination was performed on a SHIMADZU Inertsil C18(250 mm×4.6 mm,5 μm)column.The mobile phase consisted of acetonitrile and water with the ratio of 40∶60, and the flow rate was 1.0 ml·min-1.The detection wavelength was 210nm, the column temperature was 40℃, and the injection volume was 10 μl.A colorimetric method was used to detect total flavonoids with the detection wavelength of 500 nm.Results: The calibration curve of Saikosaponin a, d and total flavonoids showed a good linear relationship respectively over the range of 0.21-1.26 mg·ml-1(r=0.999 6),0.25-1.51 mg·ml-1(r=0.9997) and 4.00-25.00 μg·ml-1(r=0.999 6).The average recovery was 99.27%(RSD=2.15%, n=6),99.4%(RSD=2.14%,n=6)and 99.03%(RSD=1.34%,n=6), respectively.The content of saikosaponin a and d respectively was 0.31% and 0.50% in the root, while that in the other parts was low.The content of total flavonoids was as high as 8.48% in flowers, and that in leaves, stem and root reduced in turn.Conclusion: The aerial parts of Hollow bupleurum are rich in flavonoids, and the content of saikosaponin in root is higher, therefore, the whole plant with root is more reasonable in the clinical use.

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Content Determination of Ferric Iron and Ferrous Iron in Ferrous Succinate Tablets by Ion Chromatography-Inductively Coupled Plasma Mass Spectrometry

Yagang FAN ; Ying WANG ; Wensong ZUO

China Pharmacist.2017;20(5):956-958.

Objective: To establish a content determination method for ferric iron and ferrous iron in ferrous succinate tablets.Methods: Using a Dionex RFICTM protection column (4 mm×50 mm)and a Dionex RFICM Ion PacRCS5A analytical column (4 mm×250 mm), the eluent solution consisted of 7 mmol·L-1 dipicolinic acid, 66 mmol·L-1 potassium hydroxide, 5.6 mmol·L-1 potassium phosphate monobasic and 74 mmol·L-1 formic acid.The flow rate was 1.5 ml·min-1, the column temperature was 30.0℃ and the injection volume was 1.3 μl.Results: Fe3+ showed good linearity within the range of 0.5-15 μg·ml-1(r=1.000 0), Fe2+ showed good linearity within the range of 25-200 μg·ml-1(r=1.000 0), and the average recovery was 103.6%(RSD=2.7%, n=9)and 98.3%(RSD=1.9%, n=9), respectively.Conclusion: The method is simple, reliable and accurate, and can be used for the determination of Fe3+and Fe2+ in ferrous succinate tablets.

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Determination of Ethylparaben in Potassium Chloride Solution

Yuru YANG ; Qiulian SHEN ; Qingfen WANG

China Pharmacist.2017;20(5):953-955.

Objective: To investigate the content of ethylparaben in potassium chloride solution.Methods: According to the guidance for antibacterial effect test stated in Chinese Pharmacopoeia(the 4th volume of 2015 edition), 5 standard bacterial strains including Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger were used as the challenging strains.Using the logarithm decrease of bacteria number as the index, the antimicrobial effectiveness of ethylparaben at different concentrations was studied to screen out the optimal concentration in the solution.Results: The growth of the 5 standard bacterial strains was inhibited effectively by potassium chloride solution containing 0.05% ethylparaben, which was also the minimum effective concentration.Conclusion: 0.05% Ethylparaben is suitable as the bacteriostatic agent for potassium chloride solution.

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Verification and Evaluation on Microbial Limit Test of Methodology for Changyanning Tablets in ChP 2015

Xuping LIU ; Wenting ZHANG ; Luyao YI ; Jun XIONG ; Chunhua ZHANG ; Chun XIAO

China Pharmacist.2017;20(5):946-948.

Objective: To provide a method of microbial limit test for Changyanning tablets and carry out the verification of the mothod.Methods: A plate method was used in the total aerobic microbial count and the concentration of the test liquid was 1∶100.A plate method was used in the total yeast and mold count while the concentration of the test liquid was 1∶10.The direct inoculation method was used for the detection of Escherichia coli,bile-tolerant gram-negative bacteria and Salmonella enterica subsp.Results: The recoveries of the five strains were from 0.5 to 2.0.Conclusion: The method is suitable for the microbial limit examination of Changyanning tablets.

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Research and Testing of Water Vapor Transmission of Laminated Films for Pharmaceutical Packaging

Yi YUAN ; Nansheng JIANG

China Pharmacist.2017;20(5):943-945.

Objective: To research the comparability of water vapor transmission of laminated films for pharmaceutical packaging determined by different instruments, methods and experimental conditions to provide reference and advice for the related inspection personnel.Methods: The principle, test parameters, conditions and scope of application for the testing methods for water vapor transmission in the national standard (GB) and international standards (ISO, ASTM) were compared by using three kinds of instruments based on different testing principles.Results: Different temperature and humidity conditions had great influence on the results of the same instrument.Under the same temperature and humidity, the instrument with different principles had little influence on the test results.Conclusion: Testing personnel should regularly use the standard membrane to calibrate the instrument of the sensor method.The temperature and humidity should be strictly controlled during the test.They should take measurement accuracy, personnel operation and economic loss into consideration to select the suitable method.

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Preliminary Study on Compatibility Rationality of Sodium Bisulfite in Zhengqing Fengtongning Injection

Yingying XIE ; Haiyan LONG ; Niancen PENG ; Yong ZHAO

China Pharmacist.2017;20(5):940-943.

Objective: To analyze the compatibility rationality between the raw material and auxiliary material sodium bisulfite in Zhengqin Fengtongning injection.Methods: HPLC was applied to detect the contents of the impurity and the main component in Zhengqing Fengtongning injection, and ion chromatography was applied to determine the content of sodium bisulfite in Zhengqing Fengtongning injection.The changes of impurity, main component and sodium bisulfite among the samples were compared before and after the stress testing (high temperature at 40℃, 60℃ and illumination at 4 500 lx).LC-MS-MS was used to identify the structures of the impurities.Results: The impurity in Zhengqing Fengtongning injection was the combination of the raw material and sodium bisulfite.Conclusion: It is irrational for Zhengqing Fengtongning injection to use sodium bisulfite as the antioxidant.

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Effects of β-Cyclodextrin from Different Sources on Inclusion Rate of Menthol

Guiying JIN

China Pharmacist.2017;20(5):938-940.

Objective: To compare the inclusion rate of menthol with β-cyclodextrin (β-CD) from different sources.Methods: β-Cyclodextrin-menthol inclusion complexes were prepared by a grinding method.The inclusion compound was verified by thin layer chromatography (TLC), powder X-ray diffraction (PXRD) and gas chromatography (GC).The optimized conditions of PXRD were as follows: the graphite monochromator was Cu Kα, the voltage was 40 kV, the current was 40 mA, the 2θ scanning range was from 3° to 35°, the scanning step was 0.02° and the scanning rate was 5°·min-1.The optimized conditions of GC were as follows: an Agilent DB-wax capillary column, the column temperature was 120°, the inlet temperature was 250°, the detector temperature was 250° and the split ratio was 10∶1.Results: The results of TLC and PXRD proved the formation of inclusion complexes.The inclusion rate of menthol with β-CD from home and abroad was 25% and 47.9%, respectively.Conclusion: The method is simple, accurate and rapid, which can be used to determine the inclusion rate of β-CD from different sources.The results show that the inclusion effect of imported β-CD is better than that of domestic β-CD.

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Determination of Content and Content Uniformity of Memantine Hydrochloride Dispersible Tablets by an Internal Standard Method of GC

Chunxia WANG ; Yonghui GUO ; Xuejing HAN ; Jianguo JIANG

China Pharmacist.2017;20(5):935-937.

Objective: To establish a GC method for the determination of content and content uniformity of memantine hydrochloride dispersible tablets.Methods: The sample was dissolved in water, alkalified by sodium hydroxide solution and extracted by methylene chloride.An HP-5 gas chromatography column (50 m×0.32 mm, 1.05 μm) was used.The column temperature was programming increased, and the initial temperature maintained at 120 ℃ for 3 min, and then raised to 220 ℃ at a rate of 10℃·min-1 and maintained for 7 min.A hydrogen flame ionization detector (FID) was used and the split ratio was 1∶1.The inlet temperature was 230 ℃ and the detector temperature was 260 ℃.The injection volume was 1 μl and the carrier gas was nitrogen with high purity at a flow rate of 3.0 ml·min-1.Adamantane was used as the internal standard, and the internal standard method was used for the calculation.Results: The calibration curve was linear over the range of 0.05-1.0 mg·ml -1 (r=0.999 7).The detection limit and the limit of quantification was 1.1 ng and 3.3 ng, respectively.The average recovery was 100.2% (RSD =0.73%, n=9).Conclusion: The method has the advantages of simple operation, small extraction process toxicity, little environmental pollution, high accuracy and high specificity, and can be used for the determination of content and content uniformity of memantine hydrochloride dispersible tablets.

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Determination of Amidozon and Amantadine Hydrochloride in Compound Amantadine Hydrochloride Tablets by HPLC-ELSD

Yiqing LIU ; Liang FENG

China Pharmacist.2017;20(5):931-932.

Objective: To establish a method for the determination of amidozon and amantadine hydrochloride in compound amantadine hydrochloride tablets by HPLC-ELSD.Methods: The analytical column was an Agilent Eclipse Plus C18 column (250 mm×4.6 mm, 5 μm).The mobile phase consisted of 0.1% trifluoroacetic acid solution-acetonitrile (85∶15) and the flow rate was 0.7 ml · min-1.The column temperature was room temperature.Both evaporation temperature and atomization temperature were 40 ℃.The flow rate of carrier gas (nitrogen) was 1.8 L · min-1 and the injection volume was 10 μl.Results: The peak area and logarithm of injection volume of ampicrine showed a good linear relationship within the range of 606.72-3 033.60 μg · ml-1 (r=0.999 7), and that of amantadine hydrochloride showed a good linear relationship within the range of 400.96-2 004.80 μg·ml-1 (r=0.999 4).The average recovery was 99.5% and 99.3%, and RSDs was 0.35% and 0.40%(n=9), respectively.Conclusion: The method is simple, rapid, accurate and reproducible, and suitable for the determination of aminopyrine and amantadine hydrochloride in compound amantadine aminopyrine tablets.

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