摘要

This paper describes the development and validation of a HPLC method (216nm) for the quantitation of Zidovudine, Lamivudine and Nevirapine in pure form for pharmaceutical formulations. The method showed to be linear (r(2) > 0.999), precise (R.S.D. < 0.80%), accurate (recovery of 100.95% for Zidovudine, 100.73 % for Lamivudine and 99.94% for Nevirapine), specific and robust. Three batches of Zidovudine, Lamivudine, Nevirapine tablets were assayed by the validated method. The Zidovudine contents in the tablets samples varied from 99.82 to 101.43%, The Lamivudine content in the tablets samples varied from 99.28 to 101.24% while Nevirapine content varied from 100.56 to 101.35%.
The developed method showed to be a simple and suitable technique to quantify the antiretroviral and might be employed for quality control analysis, as well as in other matrices, such as plasma. The ZID, LAM, NEV tablets analyzed by the validated method showed adequate quality and drug contents in concordance with the labeled amount.

  • 出版日期2013-9