Introduction: Inula helenium L. is a medicinal plant widely used in traditional Mongolian and Tibetan medicine. Its roots and rhizomes contain active compounds, including sesquiterpene lactones (alantolactone and isoalantolactone), inulin, flavonoids, and essential oils, with anti-inflammatory, antimicrobial, and immunomodulatory properties. This study evaluates the quality of Inula helenium L. roots and quantifies their key active compounds in accordance with pharmacopoeial standards. Methods: The roots of Inula helenium L. cultivated in the Medicinal Plant Botanical Garden of Monos Group were used as raw material. Physicochemical parameters, including moisture, total ash, acid-insoluble ash, and extractive values, were determined according to pharmacopoeial methods. Qualitative analysis was carried out using color reactions for polysaccharides and thin-layer chromatography for the identification of sesquiterpene lactones. Quantitative analysis was performed using spectrophotometry for total polysaccharides and high-performance liquid chromatography (HPLC) for the determination of alantolactone and isoalantolactone. Conclusion The physicochemical parameters of Inula helenium L. root were standardized, with total inulin content determined as 47.13±0.45%, alantolactone as 1.41±0.02%, and isoalantolactone as 1.33±0.02%. Analytical methods for inulin, alantolactone, and isoalantolactone were validated according to ICH Q2(R2) guidelines, confirming the possibility of updating the MNS standard or developing a manufacturer’s pharmacopoeial monograph based on these validated methods.

Introduction: Ursodeoxycholic acid (UDCA) is used to treat liver and biliary disorders, including neonatal jaundice. In neonatal practice, UDCA administered orally (10–30 mg/kg/day, divided doses) shortens phototherapy duration and reduces serum total bilirubin. A suspension dosage form may mask bitter taste, improve dissolution and bioavailability, and is not currently registered in Mongolia. To develop and evaluate suspension formulations of UDCA and to identify an optimal composition and manufacturing technology. Methods: UDCA drug substance was characterized according to the European Pharmacopoeia (EP 11.0). Five suspension formulations (A1–A5) were prepared using wet-milling (size-reduction) technology and appropriate excipients. Physical, chemical and microbiological quality attributes of the suspensions were assessed per the United States Pharmacopeia (USP 2021) and microbiological methods of the Pharmacopoeia of the Russian Federation (GOST 2018). Assays were performed by validated chromatographic methods; measurements were performed in triplicate (n=3).
The UDCA raw material met pharmacopeial specifications and was suitable for use. All five formulations were uniform and free of agglomerates by visual inspection. Formulation A5 met USP acceptance criteria for pH (4.5 ± 0.02), sedimentation volume (0.91 ± 0.20 mL), density (1.14 ± 0.005 g/cm3), viscosity (1583.5 ± 0.38 mPa·s), fill volume (150 ± 0 mL) and active substance content (96.6 ± 0.05%), and complied with microbiological limits. Other formulations failed one or more quality attributes (notably pH, assay or sedimentation). Conclusion The UDCA raw material complied with pharmacopeial quality standards. Among tested variants, formulation A5 satisfied critical quality attributes for a stable suspension and was identified as the optimal formulation with respect to composition and manufacturing process.

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.

Introduction: A joint research team of the Drug Research Institute аndMonos pharm Co.ltd is conducting an experiment to produce of “Darmon” tablets.Idridoids are one of the predominant biological active compound in “Darmon” tablets and will be an important indicator of the quality of the drug. Objectives: This is the first report on the determination of iridoids by spectrophotometric method in “Darmon” tablets. Methods: The amount of total iridoids of “Darmon” tablets was confirmed by spectrophotometry and the absorbance was measured at 238 nm. Geniposide (98%, Xilong Scientific Co., Ltd) was used as the standard substance. Results: The developed spectrophotometric method showed good linearity (R²=0.9989), high precision (RSD<2%) and a good recovery (96.01-104.48%). All the validation parameters of the spectrophotometric method were found to be within the permissible limits according to the ICH guidelines. Conclusions The method was robust, accurate and reliable for the quality control of “Darmon” tablets.