Simultaneous stability indicating rp-hplc method development and validation of abacavir, dolutegride and lamivudine in bulk and pharmaceutical formulation

Abstract

A fresh analytical approach was created to estimation of Abacavir, Dolutegravir and Lamivudine in bulk and its pharmaceutical formulation. The sensitive, précised and accurate method were developed by using waters HPLC system equipped with quaternary gradient pump. The column was used Agilent TC-C₁₈ (2) 5µm [4.6mm x 250mm] and mobile phase was Methanol: Water (70:30). The mobile phase flow rate was 1 mL/min, and the PDA detector detected it at 257 nm. The procedure was carried out at room temperature. The retention time of the ABV, DTV and LVD were found to be 2.6, 2.9 and 6.6 min. The % RSD values in precision was >2%. It was discovered that the method's accuracy ranged from 99.95% -100.01% for ABV, 99.95%-100.13% for DTV and 99.95%-100.04% for LVD. The limits of detection and quantification values were obtained 0.57µg/mL and 1.89µg/mL respectively. The range of linearity concentration was found to be 150-450µg/mL for ABV, 12.5-37.5µg/mL for DTV and 75-225µg/mL for LVD, it shown wider linearity concentration range. The technique demonstrated good robustness. The parameters of flow rate (±0.2 mL) and wavelength (±2 nm) were changed and obtained good % assay values. The technique demonstrated its capacity to withstand various stress conditions, including UV, peroxide, acidity, and alkalinity. The acidity and alkalinity stress studies were performed by 0.1N HCl and 0.1N NaOH. The peroxide stress study was carried out by 3% hydrogen peroxide at room temperature. UV-Light carried out the UV degradation investigation. The technique was applied to the routine HPLC analysis of bulk Abacavir, Dolutegravir, and Lamivudine as well as its pharmaceutical dosage form.