Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Determination of Molnupiravir in Capsule Dosage Form

IF 0.4 4区医学 Q4 PHARMACOLOGY & PHARMACY

Indian Journal of Pharmaceutical Sciences Pub Date : 2023-01-01 DOI:10.36468/pharmaceutical-sciences.1156

R. B. Patel, R. V. Solanki, S. P. Chauhan, D. M. Patel

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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.

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高效液相色谱法测定莫诺比拉韦胶囊剂型的稳定性及验证

建立了一种简单、快速、新型的反相高效液相色谱法，用于定量莫努比拉韦胶囊剂型，该胶囊剂型最近被批准用于印度中度冠状病毒病患者的III期临床试验。采用Eclipse Plus C18 (150×4.6 mm, 5µ)色谱柱，以缓冲液(pH 4.5)和甲醇(70:30 v/v)为流动相，反相高效液相色谱法对Molnupiravir进行色谱分离。方法按照国际协调理事会Q2 (R1)指南的建议进行验证。在49.80 ~ 149.40µg/ml浓度范围内线性良好。决定系数(r2, n=3)的平均值为0.9999。精密度值(相对标准偏差百分比)和总体回收率是可以接受的。该方法有效地分离了药物及其降解产物。因此，它可以作为一种稳定性指示分析方法，用于药物制剂中莫那匹拉韦的常规分析。

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来源期刊

Indian Journal of Pharmaceutical Sciences PHARMACOLOGY & PHARMACY-

自引率

0.00%

发文量

审稿时长

2 months

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.