Validated RP-HPLC method for quantification of metolazone in bulk drug and formulation

A simple, selective, precise, and accurate High Performance liquid Chromatographic method for the analysis of Metolazone in bulk drug and pharmaceutical formulations was developed and validated in the present study. The mobile phase consists of a mixture of Buffer, Methanol, and Acetonitrile in the proportion 65:28:7. Mix well, adjust the pH Metolazone to 3.0 ± 0.05 with Phosphoric acid. This was found to give a sharp peak of Metolazone at a retention time of 12.568 min. HPLC analysis of Metolazone was carried out at a wavelength of 235nm with a flow rate of 1.1 mL/min. The linear regression analysis data for the calibration curve showed a good linear relationship with a regression coefficient of 0.999 in the concentration range of 50 ppm to 150 ppm. The linear regression equation was y=39.19x75.32. The developed method was employed with a high degree of precision and accuracy for the analysis of Metolazone developed method was validated for accuracy, precision, robustness, detection and quantification limits as per the ICH guidelines. The wide linearity range, accuracy, sensitivity, short retention time and composition of the mobile phase indicate that this method is better for the quantification of Metolazone.

Author(s): P. Suguna

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