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Development and Validation of RP-HPLC method for simultaneous estimation of Lamivudine and Efavirenz in the Pharmaceutical Dosage Form


Manikanta Kumar A , B. Naga Sandhya , Mahesh Nasare , V. V. L. N Prasad , Prakash V Diwan

Abstract

A simple, specific, accurate and precise reverse phase high performance liquid chromatography (RP-HPLC) method have been developed, which can separate and quantitatively estimate lamivudine and efavirenz in pharmaceutical dosage form. The chromatographic separation for lamivudine and efavirenz was achieved with mobile phase containing 0.1 % triethylamine (pH adjusted to 5.11 with 0.1% orthophosphoric acid) and acetonitrile (30:70 % v/v), reverse phase phenomenex® (Luna 5μ C18(2) 100A (250 × 4.60 mm i.d) column in isocratic mode at room temperature and UV detection at 245 nm. The compounds were eluted at a flow rate of 1.0 ml/min. The retention times of lamivudine and efavirenz were found to be 2.271±0.177 min and 7.267±0.513 min respectively. The above method was validated in terms of linearity, accuracy, precision, Limit of Detection (LOD), Limit of Quantification (LOQ) etc. in accordance with ICH guide lines. The developed method was free from interferences due to excipients present in tablets. The method was rapid, simple and suitable for routine quality control analysis.




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