Abstract

A NEW STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF DORAVIRINE, LAMIVUDINE AND TENOFOVIR IN PHARMACEUTICAL DOSAGE FORM

Bijjolla Harish*, Sridhar Siddiraju, P. Ajay Kumar, C. Parthiban and M. Sudhakar

ABSTRACT

A simple, rapid and robust reverse phase HPLC method was developed and validated for the simultaneous estimation of Doravirine, Lamivudine and Tenofovir in pharmaceutical dosage form with forced degradation studies. Chromatographic conditions used are stationary phase Agilent C8 (150mm*4.6mm 5μm), Mobile phase 0.1% Orthophosphoric acid and Methanol as mobile phase in the ratio of 50:50 and flow rate was maintained at 0.9ml/min, detection wave length at 231nm, Temperature was set to 30oC. The mean retention times of Doravirine, Lamivudine and Tenofovir were found to be 2.265, 2.880 and 3.874 min respectively. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 25% to150 % levels, R2 value was found to be as 0.999. All other validation parameters like precision, accuracy, LOD, LOQ and robustness were found to be within the limits. % recovery was obtained as 100.28%, 100.16% and 99.87% for Doravirine, Lamivudine and Tenofovir respectively. The proposed method was found to be suitable and accurate for simultaneous estimation of Doravirine, Lamivudine and Tenofovir NO in Pharmaceutical dosage form.

Keywords: Doravirine, Lamivudine and Tenofovir, RP-HPLC.