Thu, 14 Dec 2017

HPLC Isocratic Elution Method for Quantification of Tenofovir Disoproxil and Emtricitabine Simultaneously In Bulk and Tablet Formulation

Eegala Bheema Shankar1*, Challa Gangu Naidu2, Vangala Saidi reddy1

1.Clearsynth Research centre, Hyderabad, Telangana, India - 500076.

2.Analytical chemistry division, Indian institute of Chemical Technology, Hyderabad, Telangana, India- 500607.


ABSTRACT

An HPLC method has been developed for simultaneous estimation of tenofovir disoproxil and emtricitabine in bulk and in their tablet dosage form. Separation and analysis of both drugs was achieved on Supelco C18 (250 x 4.6 mm; 5 µm particle size) analytical column with temperature set at 25˚C. The best chromatographic condition was found as an isocratic mobile phase consisting of 0.2 M ammonium acetate (pH 4.5) and methanol in a ratio of 65: 35 (% v/v) at a flow rate of 1.2 ml/min for 6 minutes. The retention of emtricitabine and tenofovir disoproxil was found to be 3.020 min and 4.264 min, respectively. The method was validated according to the International Conference on Harmonization guidelines and various validation parameters (system suitability, selectivity, linearity, precision, accuracy, limit of detection, limit of quantification and robustness) were determined. The results of validation parameters are satisfactory. Applicability of the developed and validated HPLC method was checked in tablet dosage form.

Keywords: Tenofovir disoproxil, Emtricitabine, HPLC method, Validation, Estimation.

 


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