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A novel, precise, accurate, rapid and cost effective isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method was developed, optimized and validated for the estimation of Abacavir and Lamivudine in bulk and pharmaceutical dosage forms. The drugs were estimated using Phenomenex Gemini C18 (4.6mm×150mm, 5.0 µm) particle size column. A mobile phase composed of tri ethylamine buffer and methanol in proportion of 32:68 v/v, at a flow rate of 1.0 ml/min was used for the separation. Detection was carried out at 248 nm. The linearity range obtained was 30-70 µg/ml for Darunavir and 10-50 µg/ml for Cobicistat with retention times (Rt) of 3.297 min and 5.405 min for Abacavir and Lamivudine respectively. The correlation coefficient values were found to be 0.999 & 0.999. Precession studies showed % RSD values less than 2 % for both the drugs in all the selected concentrations. The percentage recoveries of Abacavir and Lamivudine were found to be 100.1873% for Darunavir and 100.748% for Cobicistat respectively. The assay results of Abacavir and Lamivudine were found to be 99.82%. The limit of detection (LOD) and limit of quantification (LOQ) were 2.6µg/ml and 7.8µg/ml for Darunavir and 3.4µg/ml 10.2µg/ml for Cobicistat respectively. The proposed method was validated as per the International Conference on Harmonization (ICH) guidelines. The proposed validated method was successfully used for the quantitative analysis of commercially available dosage form.


Abacavir and Lamivudine RP-HPLC ICH Guidelines Validation

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