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Abstract

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Spironolactone and Furosemide, in its pure form as well as in pharmaceutical dosage form. Chromatographic separation was carried out on a Symmetry C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: TEA Buffer pH 4.2 (40:60v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 272 nm. The retention time of the Spironolactone and Furosemide was 2.781, 4.048 ±0.02min respectively. The proposed method was validated for various ICH parameters like linearity, limit of detection, limits of quantification, accuracy, precision, range and specificity. The method produce linear responses in the concentration range of 5-25mg/ml of Spironolactone and 9.375-46.875 mg/ml of Furosemide. The method precision for the determination of assay was below 2.0%RSD. The proposed method is applicable to routine analysis of Spironolactone and Furosemide in bulk and pharmaceutical formulations.

Keywords

Spironolactone Furosemide RP-HPLC Accuracy Robustness

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