Abstract

A RESEARCH ON DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF METOLAZONE IN TABLET DOSAGE FORM

Mayuri A. Patil*, Dr. S. T. Patil and Dr. S. P. Pawar

ABSTRACT

The aim of this research work was to develop simple, precise and rapid RP-HPLC methods for analysis of Metolazone in tablet dosage form. A rapid and reliable RP-HPLC method was developed and validated for estimation of Metolazone in tablet dosage form. The RP-HPLC method was perform Intelligent C 18 Grace (Torrance, CA) C18 (250mmX 4.6mm,5μm) 5μm particle size in isocratic mode, and the sample was analyzed using Methanol 85 ml and water 20=15ml (85M+15(0.05%OPA) 240NM) as a mobile phase at a flow rate of 0.8ml/min and detection at 240nm. By The retention time for Metolazone were found to be 4.1833min. The method was applied to marketed tablet formulations. The Tablet assay was performed for this was validated for accuracy, precision, linearity, specificity and sensitivity in accordance with ICH guidelines. Validation revealed the method is specific, rapid, accurate, precise, reliable, and reproducible. Calibration plots were linear over the 10-40 μg/ml for Metolazone and recoveries from Tablet dosage form were between 98 and 102%. The method can be used for routine of the quality control in pharmaceuticals. The UV-Spectrophotometric method was found to be simple, economical and rapid as compared to RP-HPLC. But, RP-HPLC method was found to be more accurate, precise, and robust. So these methods can be used for routine analysis of Metolazone in tablet dosage form.

Keywords: Metolazone, RP-HPLC, Validation, Tablet.