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A New Validated Rp-HPLC Method Development for the Simultaneous Estimation of Lamivudine, Tenofovir and Efavirenz in Pure and its Pharmaceutical Dosage Form

Nageswara Rao*

This study was designed to develop a reliable method for estimation of 3TC, TFV, and EFV in pure and its pharmaceutical dosage form by RP-HPLC. Method: A simple, rapid, accurate, precise, robust and isocratic reverse phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of 3TC, TFV and EFV in combined dosage form. The method was developed by using Inertsil ODS-3V (250 × 4.6, 5 μm) column, with Mobile phase composition of Acetonitrile: 1% IPA in the ratio of 85:15 at a flow rate of 1 ml/min and the effluents were monitored at 256 nm using PDA detector. Results: 3TC, TFV and EFV drugs were eluted at retention time of 2.4, 2.8 and 4.5 min (± 0.5). The proposed method was validated as per ICH guidelines. The correlation coefficient (R²) was found to be 0.999. All the parameters were found to be within the limits. The recovery studies were carried out and found to be within 98-102% and the %RSD was found to be ˂2%. Limit of Detection and Limit of Quantification of 3TC, TFV and EFV were found to be 0.06, 0.09, 0.17 μg/ml and 0.18, 0.27, 0.53 μg/ml respectively. Conclusion: The Analysis time for the proposed method is less which can be applied for the multiple samples in less time. Hence the proposed method was found to be novel, simple, accurate and robust and the validation studies indicated that the proposed methods are suitable for the routine quality analysis of the combined dosageform.