Analytical method development and validation of simultaneous estimation of Metolazone and Spironolactone in bulk and pharmaceutical dosage form by RP-HPLC
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2014, Vol 2, Issue 6
Abstract
This paper describes a novel, simple, precise, accurate, sensitive, rapid reversed-phase liquid chromatographic method for simultaneous estimation of Metolazone and Spironolactone in bulk and pharmaceutical dosage form. The chromatographic separation was achieved on WATERS E 2695 HPLC separation module equipped with ALTIMA column (150mm×4.6mm×5μm) and UV-Detector (Waters) using Ortho phosphate buffer and Acetonitrile in the ratio of (35:65v/v) as mobile phase at a flow rate of 1.0ml/min. The detection was carried out at 234nm.The retention time of Metolazone and Spironolactone was found to be 2.127 and 4.103 min respectively. Linearity was observed in the concentration range of 1.25-7.5μg/ml for Metolazone and 12.5-75μg/ml for Spironolactone %Recoveries obtained for Metolazone and Spironolactone were 100.1% & 99.98% respectively .The %RSD below 2.0 shows the high precision of proposed method. The method was validated for precision, Recovery, Specify and Detection and Quantification limits in accordance with ICH guidelines.
Authors and Affiliations
G. Pallavi, A. Ravi Kumar
Keywords
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