Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Determination of Molnupiravir in Capsule Dosage Form
R. B. Patel, R. V. Solanki, S. P. Chauhan, D. M. Patel
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引用次数: 0
Abstract
A simple, rapid and novel reverse phase-high performance liquid chromatography method was developed for quantification of molnupiravir in its capsule dosage form which is recently approved for phase III clinical trials in moderate coronavirus disease patients in India. The chromatographic separation of Molnupiravir was achieved on reverse phase-high performance liquid chromatography using Eclipse Plus C18 (150×4.6 mm, 5 µ) column with buffer (pH 4.5) and methanol (70:30 v/v) as mobile phase. Method was validated in accordance with recommendations of International Council for Harmonisation Q2 (R1) guidelines. The linearity of the method was found to be excellent over the concentration range of 49.80-149.40 µg/ml. The mean of the coefficient of determinations (r2, n=3) was found to be 0.9999. The precision values (percentage relative standard deviation) and overall percentage recovery was found to be acceptable. The proposed method effectively separated the drug from its degradation products. Hence, it can be used as a stability-indicating assay method for the routine analysis of molnupiravir in pharmaceutical formulations.
期刊介绍:
The Indian Journal of Pharmaceutical Sciences (IJPS) is a bi-monthly Journal, which publishes original research work that contributes significantly to further the scientific knowledge in Pharmaceutical Sciences (Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy and Phytochemistry, Pharmacology and Therapeutics, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Pharmacovigilance, Pharmacoepidemiology, Pharmacoeconomics, Drug Information, Patient Counselling, Adverse Drug Reactions Monitoring, Medication Errors, Medication Optimization, Medication Therapy Management, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest). The Journal publishes original research work either as a Full Research Paper or as a Short Communication. Review Articles on current topics in Pharmaceutical Sciences are also considered for publication by the Journal.