A newly validated HPLC method development for simultaneous estimation of ritonavir and lopinavir


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1

Abstract :

The aim of the present work was to develop a isocratict RP-HPLC for simultaneous analysis of ritonavir and lopinavir in tablet dosage form. Method: chromatographic system was optimized using a Agilent XDB C18(150 x 4.6mm,5µm) column with potassium dihydrogen phosphate (pH 4.6) and acetonitrile in the ratio of 45;55, as a mobile phase, at a flow rate of 1.0 ml/min. detection was carried out at 215nm by a photodiode array detector. Result: ritonavir and lopinavir were eluted with retention times of 4.821 and 3.814mins respectively. Beer’s lambert’s law was obeyed over the concentration ranges of 12.5 to 50µg/ml and 50 to 200µg/ml for ritonavir and lopinavir, respectively. Conclusion: the high recovery and low coefficients of variation confirm the suitability of the method for simultaneous analysis of both drugs in a tablet dosage form. Statistical analysis proves that the method is sensitive and significant for the analysis of ritonavir and lopinavir in pure and in pharmaceutical dosage form without any interference from the excipients. The method was validated in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible.
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