紫外分光光度法定量测定莫那匹拉韦的含量

P. Jain, Manali Bhamare, S. Surana
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引用次数: 2

摘要

建立了一种简便、快速、准确、经济的紫外分光光度法测定原料药和制剂中莫诺匹拉韦的含量。Molnupiravir在蒸馏水中的λ为235 nm。为零级药品和零级AUC。该药物的AUC范围为228.00 ~ 243.40 nm。在5 ~ 30µg/ml浓度范围内呈线性关系,相关系数为0.999。将所提出的方法应用于药品配方中,发现99.99 %的药物量与标签声明完全一致。通过在80%、100%和120% w/w下的回收率实验,验证了该方法的准确性。方法A的回收率为98.15% ~ 99.97%,方法b的回收率为98.85% ~ 99.56%,rsd值较低,说明了方法的准确性和重复性。对该方法的精密度进行了日内、日间变化和重复性的研究。% rsd值小于2表示该方法是精确的。在两位分析人员的帮助下,研究了所提出方法的耐用性。该方法是一种快速、经济的质量控制工具,可用于原料药和制剂的常规分析。
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Quantitative estimation of molnupiravir by UV- Spectrophotometric method
A simple, rapid, accurate and economical UV-spectrophotometric method has been developed for estimation of Molnupiravir from bulk and pharmaceutical formulation. The λ of Molnupiravir in Distilled water was found to be 235 nm. The is for zero order of drug and for Zero order AUC. The AUC of the drug was found to be in the range of 228.00 – 243.40 nm. The drug follows linearity in the concentration range 5-30 µg/ml with correlation coefficient value 0.999. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 99.99was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120 % w/w. The % recovery was found to be in the range 98.15%– 99.97% for method A and 98.85% — 99.56% for method B. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. The above method was a rapid and cost-effective quality-control tool for routine analysis of Molnupiravir in bulk and in pharmaceutical dosage form.
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