Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE AND EFAVIRENZ IN COMBINED TABLET DOSAGE FORM BY RP-HPLC

N. Srinivasa Rao*, Dr K. Venkataramana, P. Srinivas, R. Meghana, P. Anitha

ABSTRACT

An accurate, precise, reproducible, gradient and stability indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed and validated for the estimation of Lamivudine, Tenofovir disoproxil fumarate and Efavirenz in pharmaceutical dosage forms. In this method Waters C18 (75x4.6mm, 5μ) column with gradient mobile phase containing methanol and water in different ratios were used. The flow rate was 1.0 ml/min. and the detection wavelength was 260nm. The linearity was observed in the range of 60 – 450 ppm, 60 - 450 ppm and 120 – 900 ppm for Lamivudine, Tenofovir disoproxil fumarate and Efavirenz with correlation coefficient of 0.9992, 0.9992, and 0.9994 respectively. Retention times were 2.394, 5.827 and 9.700 min for Lamivudine, Tenofovir disoproxil fumarate and Efavirenz. The proposed method was validated for linearity, accuracy, precision, robustness and stress testing of the drugs was performed according to the International Conference Harmonization (ICH) guidelines in order to validate the stability indicating power of the analytical procedures. Thefore the proposed method can be applied for routine quality control analysis of pharmaceutical dosage forms used for multidrug therapy containing Lamivudine, Tenofovir disoproxil fumarate and Efavirenz.

Keywords: HPLC, multidrug therapy, ICH, Validation, TRIODAY TABLETS.