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A Validated Stability Indicating RP-HPLC Method for the Determination of Tenofovir in Bulk and Tablet Dosage Forms


Pradeep Kumar, Suresh C. Dwivedi, Ashok Kushnoor

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Keywords

Tenofovir, RP-HPLC, Stability studies, Validation, ICH guidelines

Abstract

A rapid, precise, accurate, specific and simple RP-HPLC method was developed for the estimation of Tenofovir in its tablet form. A High performance liquid chromatograph 10AT SHIMADZU- SPD10A, using Phenomenex - Luna RP-18(2),250X4.6mm, 5 m column, with mobile phase composition of Acetonitrile: water [78:22 %(v/v)] was used. The flow rate of 1.0 mL min-1 and effluent was detected at 260 nm. The retention time of Tenofovir was 5.541 minutes. Linearity was observed over concentration range of 500-4000 ng mL-1. The Limit of detection was found to be 74.80 ng mL-1 while quantification limit was 226.68 ng mL-1. The accuracy of the proposed method was determined by recovery studies and found to be 98.465 to 100.003%. Commercial tablet formulation was successfully analyzed using the developed method and the proposed method is applicable to stability studies and routine analysis of Tenofovir in bulk and pharmaceutical formulations. The proposed method was validated for various ICH parameters like linearity, limit of detection, limits of quantification, accuracy, precision, range and specificity.