A new analytical method for determination of tenofovir disoproxil fumarate and emtricitabine 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.v1i3.118

P. Vani

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引用次数: 1

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 Tenofovir Disoproxil Fumarate and Emtricitabine in pharmaceutical dosage form. Chromatographic separation of Tenofovir Disoproxil Fumarate and Emtricitabine was achieved on Waters Alliance -2695, by using Luna C18 (250mm x 4.6mm, 5µm) column and the mobile phase containing 0.1% TEA adjusted pH-2.5 with OPA & ACN in the ratio of 60:40 v/v. The flow rate was 1.0 ml/min, detection was carried out by absorption at 261 nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Tenofovir Disoproxil Fumarate and Emtricitabine were NLT 2000 and should not more than 2 respectively. The linearity of the method was excellent over the concentration range 30-450 µg/ml and 20-300 µg/ml for Tenofovir Disoproxil Fumarate and Emtricitabine 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 Tenofovir Disoproxil Fumarate and Emtricitabine 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富马酸替诺福韦和恩曲他滨含量的新方法

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)方法，用于富马酸替诺福韦二氧吡酯和恩曲他滨药物剂型的定量分析。采用Waters Alliance -2695，色谱柱为Luna C18 (250mm × 4.6mm, 5µm)，流动相为0.1% TEA调整pH-2.5, OPA和ACN的比例为60:40 v/v，对富马酸替诺福韦二氧吡酯和恩曲他滨进行色谱分离。流速为1.0 ml/min，室温下采用光电二极管阵列检测器在261 nm处吸收检测。富马酸替诺福韦和恩曲他滨的理论板数和尾因子分别为nlt2000和不大于2。富马酸替诺福韦二氧吡酯和恩曲他滨在30 ~ 450µg/ml和20 ~ 300µg/ml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。该方法简便、经济、适用、精密度高、准确度高、稳扎稳打，可用于富马酸替诺福韦二氧吡酯的定量分析和恩曲他滨的稳定性研究。

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International Journal of Research In Pharmaceutical Chemistry and Analysis

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