A new analytical method for determination of dolutegravir and rilpivirine in pharmaceutical formulations by RP-HPLC method

International Journal of Research In Pharmaceutical Chemistry and Analysis Pub Date : 2019-07-28 DOI:10.33974/ijrpca.v1i3.119

Kanchipogu usha rani, P. V. Rao, N. Rao

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引用次数: 3

Abstract

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Dolutegravir and Rilpivirine in pharmaceutical dosage form. Chromatographic separation of Dolutegravir and Rilpivirine was achieved on Waters Alliance -2695, by using Luna C18 (250mm x 4.6mm, 5µm) column and the mobile phase containing 0.1% OPA & ACN in the ratio of 50:50 v/v. The flow rate was 1.0 ml/min, detection was carried out by absorption at 245 nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Dolutegravir and Rilpivirine were NLT 2000 and should not more than 2 respectively. The linearity of the method was excellent over the concentration range 10-150 µg/ml and 5-75 µg/ml for Dolutegravir and Rilpivirine respectively. The correlation coefficient was 0.999. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Dolutegravir and Rilpivirine study of its stability.

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建立了反相高效液相色谱法测定制剂中多替格拉韦和利匹韦林含量的新方法

建立了一种简便、快速、精确、灵敏、重现性好的反相高效液相色谱(RP-HPLC)定量分析药物剂型多替格拉韦和利匹韦林的方法。Dolutegravir和Rilpivirine的色谱分离采用Waters Alliance -2695，色谱柱为Luna C18 (250mm × 4.6mm, 5µm)，流动相含0.1% OPA和ACN，比例为50:50 v/v。流速为1.0 ml/min，室温下采用光电二极管阵列检测器在245 nm处吸收检测。Dolutegravir和Rilpivirine的理论极板数和尾尾因子分别为nlt2000，不大于2。dolutegravity和Rilpivirine分别在10 ~ 150µg/ml和5 ~ 75µg/ml的浓度范围内线性良好。相关系数为0.999。所有测量峰面积的相对标准偏差总是小于2.0。根据ICH指南对该方法进行了验证。结果表明，该方法简便、经济、适用、精密度高、准确度高、稳健性好，可用于多替格拉韦和利匹韦林的定量分析。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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International Journal of Research In Pharmaceutical Chemistry and Analysis

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