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VALIDATED HPTLC METHOD FOR THE DETERMINATION OF EMTRICITABINE AS BULK DRUG AND IN CAPSULE DOSAGE FORM

DOI: 10.7439/ijbar.v2i7.38

Keywords: Emtricitabine , Validation , ICH guidelines , HPTLC

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Abstract:

A simple, accurate, precise, and rapid high performance thin layer chromatographic method has been developed and validated for the estimation of Emtricitabine in capsule dosage forms. The method employed TLC aluminium plates precoated with silica gel 60 F 254 as the stationary phase. The mobile phase used was a mixture of (Chloroform: Methanol 8.5: 1.5v/v). The detection of spot was carried out at 275nm. The calibration curve was found to be linear between 200 to 2200 ng mL-1 with regression coefficient of 0.9992. The proposed method can be successfully used to determine the drug content of marketed formulation. The accuracy of the proposed method was determined by recovery studies and found to be 98.79 to 99.61 %. The proposed method is applicable to routine analysis of Emtricitabine in bulk and pharmaceutical formulations. The proposed method was validated according to various ICH parameters like linearity, accuracy, precision, specificity, limits of detection, limits of quantification, range and solution stability.

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