A NEW STABILITY INDICATING UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF METOLAZONE AND SPIRONOLACTONE IN BULK AND IN ITS PHARMACEUTICAL FORMULATIONS
Keywords:
RP-UPLC, ICH, Metolazone, Spironolactone, UV-Spectroscopy, LOD, LOQAbstract
Objective: The objective of the work is to develop and validate a new, simple, highly sensitive RP-UPLC method for simultaneous estimation of Metolazone and Spironolactone in bulk and in its dosage forms.
Methods: The method was developed on a reversed-phase Hypersil Gold C18 (2.1× 100 mm, 2.7 µm) column with isocratic elution. Detection was done by UV-Spectroscopy at a detection wavelength of 235 nm. The analytical procedure was validated by assessing the specificity, linearity, precision, accuracy, limit of detection, limit of quantification, robustness and ruggedness as per ICH guidelines.
Results: The results were obtained as follows- the retention times were found to be around 2.888 min and 3.835 min, the percentage purity was observed to be 99 % w/v and 100 % w/v, the percentage recovery was found to be 99.90% and 99.9% respectively for Metolazone and Spironolactone. Calibration plots were linear (r2 > 0.999) over the concentration range of 12 to 28μg/ml for Metolazolone and 120 to 280μg/ml for Spironolactone. The LOD was 0.0002µg/ml for Metolazone and 0.01µg/ml for Spironolactone. The LOQ was found to be 0.0008µg/ml for Metolazone and 0.003µg/ml for Spironolactone.
Conclusion: The developed analytical method for the simultaneous quantitation of Metolazone and Spironolactone was found to be specific, rapid, reliable, and reproducible. No interference from any component of pharmaceutical dosage form was observed. The method is amenable to the routine analysis of large numbers of samples with good precision and accuracy.
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