首页> 外文期刊>International Journal of Pharmaceutical Sciences and Research >A NEW, SIMPLE, SENSITIVE, ACCURATE & RAPID ANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, ABACAVIR & ZIDOVUDINE IN TABLET DOSAGE FORM BY USING UPLC
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A NEW, SIMPLE, SENSITIVE, ACCURATE & RAPID ANALYTICAL METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, ABACAVIR & ZIDOVUDINE IN TABLET DOSAGE FORM BY USING UPLC

机译:使用UPLC同时估算片剂剂量形式中的拉米夫定,ABACAAVIR和齐多夫定的新方法,简便,灵敏,准确,快速的分析方法开发和验证

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The present work was undertaken with the aim to develop and validate a rapid and consistent UPLC method in which the peaks will be appear with short period of time as per ICH Guidelines. The UPLC separation was achieved on a Symmetry C18 (2.1 x 100mm, 1.7mm, Make: BEH) or equivalent in an Isocratic Mode. The mobile phase was composed of Phosphate Buffer (60%) [pH3.0] & Methanol (40%) [UPLC Grade] The flow rate was monitored at 0.25 ml per min. The wavelength was selected for the detection was 280 nm. The run time was 3min. The retention time found for the drugs Lamivudine, Abacavir and Zidovudine were 1.019 min., 1.271 min. & 1.617 min. respectively. The % recovery was found to be 98.0%- 99.0% for the drug Abacavir. The % recovery was found to be 98.0% – 99.6% for the drug Lamivudine. The % recovery was found to be 98.2% – 98.6% for the drug Zidovudine. The linearity was established in the range of 20 to 60ppm for the drug Abacavir & 10 to30ppm for the drug Lamivudine & 20 to60ppm for the drug Zidovudine. The LOD for the drugs Abacavir, Lamivudine and Zidovudine were found to be 0.002μg/ml, 0.003μg/ml, & 0.005μg/ml respectively. The LOQ for the drugs Abacavir, Lamivudine and Zidovudine were found to be 0.008μg/ml, 0.01μg/ml & 0.02μg/ml respectively. Overall the proposed method was found to be suitable, sensitive, reproducible, specific and accurate for the quantitative determination of the drug in tablet dosage form.
机译:进行本工作的目的是开发和验证一种快速且一致的UPLC方法,根据ICH指南,其中的峰将在短时间内出现。在等度模式下,在对称C 18 (2.1 x 100mm,1.7mm,Make:BEH)上实现UPLC分离。流动相由磷酸盐缓冲液(60%)[pH3.0]和甲醇(40%)[UPLC等级]组成。流速以0.25 ml / min进行监测。选择用于检测的波长是280nm。运行时间为3分钟。拉米夫定,阿巴卡韦和齐多夫定的保留时间分别为1.019分钟,1.271分钟。 &1.617分钟。分别。发现药物阿巴卡韦的回收百分比为98.0%-99.0%。发现拉米夫定的回收率是98.0%– 99.6%。发现齐多夫定的回收率是98.2%– 98.6%。线性确定为阿巴卡韦药物为20至60ppm,拉米夫定药物为10至30ppm,齐多夫定药物为20至60ppm。阿巴卡韦,拉米夫定和齐多夫定的LOD分别为0.002μg/ ml,0.003μg/ ml和0.005μg/ ml。阿巴卡韦,拉米夫定和齐多夫定的最低定量分别为0.008μg/ ml,0.01μg/ ml和0.02μg/ ml。总的来说,发现所提出的方法对于片剂剂型中药物的定量测定是合适,灵敏,可再现,特异性和准确的。

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