拉米夫定、齐多夫定、奈韦拉平片剂型的稳定性指示方法研究与验证

Shinde G. S., Jadhav R. S., Vikhe D. N.
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引用次数: 0

摘要

采用Inertsil ODS 3V C18色谱柱(5µm, 150mm × 4.6mm)为固定相,0.01M 1-辛烷磺酸:甲醇(60:40v/v, pH2.6)为流动相,建立了拉米夫定、齐多夫定和奈韦拉平的反相高效液相色谱法。流动相流速为1ml/min,运行时间为15min,检测波长为270nm。拉米夫定、齐多夫定和奈韦拉平分别在75 ~ 225µg/ml、150 ~ 450µg/ml和100 ~ 300µg/ml浓度范围内呈线性关系。拉米夫定、齐多夫定和奈韦拉平在市售制剂中%含量测定的结果分别为101.93±0.1527、100.86±0.2021和94.2±0.1527。结果表明,拉米夫定、齐多夫定和奈韦拉平的回收率分别为100.9 ~ 101.4%、100.1 ~ 100.7%和99.0 ~ 99.9%。精密度研究的RSD均小于2%,表明该方法精密度较好。该方法具有良好的线性度、准确度、精密度和鲁棒性。该方法简单、快速。可用于拉米夫定、齐多夫定和奈韦拉平药品剂型的常规质量控制分析。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability indicating Method development and Validation of Lamivudine, Zidovudine and Nevirapinein Tablet dosage form
The RP-HPLC method for Lamivudine, Zidovudine and Nevirapine was developed using Inertsil ODS 3V C18 column (5µm, 150mm × 4.6mm) as stationary phase and 0.01M 1-octane Sulphonic acid: Methanol (60:40v/v, pH2.6) as mobile phase. The mobile phase was maintained at a flow rate of 1ml/min, run time 15 min and detection was carried out at 270nm.Lamivudine, Zidovudine and Nevirapine were found to be linear in the concentration range of 75-225µg/ml, 150-450µg/ml and 100-300µg/ml respectively. The result of % assay of marketed formulation was found as 101.93±0.1527, 100.86±0.2021and 94.2±0.1527 for Lamivudine, Zidovudine and Nevirapine respectively. Accuracy of the method was determined by performing recovery study and the result were found in the range of 100.9-101.4%, 100.1-100.7% and 99.0-99.9% for Lamivudine, Zidovudine and Nevirapine respectively. Percentage RSD of precision study of these drugs were found less than 2 percent which indicated good precision of the developed method. The proposed method was validated for linearity, accuracy, precision, and robustness. The proposed method is simple, rapid. precise and reproducible hence can be applied for routine quality control analysis of Lamivudine, Zidovudine and Nevirapine in pharmaceutical dosage form.
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