Abstract

REVIEW ARTICLE: STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE BY RP –HPLC

Dr. Kuna Mangamma*, Kalidindi Sita Maha Lakshmi S. Kavya, Kuppili Sri Kavya, Korukonda Rama Priyanka

Abstract

Objective: To develop a simple, accurate, precise specific and rugged reverse phase liquid chromatographic method was developed for the simultaneous estimation of lamivudine, dolutegravir, tenofovir in bulk and tablet dosage form. The analytical method was validated according to ICH guidelines [ICH Q2(R1)]. Method: A reverse phase gradient program has been developed to separate all the four active compounds. The compounds present in different concentrations and chromatographic behaviour KH2PO4 and 1-octane sulfonic acid buffer pH 3.2 ±0.05 adjusted with trifluroacetic acid, acetonitrile and methanol was used as mobile phase (B). A gradient programming has been done, on a reverse phase kinetex biphenyl (250×4.6 mm, 5μ) with a flow rate 1mL/ min, monitored at 260nm. Results: The mean retention times of lamivudine tenofovir, dolutegravir was found to be 11.5, 26.5 and 30.0 min respectively. Conclusion: The proposed method was validated in terms of linearity, range, accuracy, precision, specificity, robustness, and stability studies and the method was successfully applied to estimation of lamivudine, tenofovir and dolutegravir in combined tablet dosage forms.

Keywords: Gradient Lamivudine, tenofovir, dolutegravir, RP –HPLC.