Method development and validation of spectrophotometric and RP-HPLC methods for simultaneous estimation of spironolactone and furosemide in bulk and combined tablet dosage forms
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The intent of the present work was to develop a simple, sensitive, accurate, precise, rapid and economical UV- spectrophotometric and reverse phase high pressure liquid chromatographic method for the simultaneous estimation of Spironolactone and Furosemide in bulk and combined tablet dosage forms. UVSpectrophotometry was carried out by simultaneous equation method using 0.02 M potassium dihydrogen phosphate buffer pH 3.5: Acetonitrile (50:50) v/v as a solvent. The linearity range was 2-14 μg mL−1 for Spironolactone and Furosemide with a correlation coefficient > 0.99. The chromatographic separation was achieved on 250 mm × 4.6 mm, hypersil BDS C18 column with particle size 5 μm, by using an isocratic mixture of 0.02 M potassium dihydrogen phosphate buffer pH 3.5: Acetonitrile: tert butyl methyl ether (49:50:1) v/v/v as a solvent at a flow rate of 1 mL min−1 and UV detection was carried out at 254 nm. The retention time were observed to be 3.666 and 6.661 minutes for Furosemide and Spironolactone respectively. The two developed methods were validated according to the ICH guidelines for accuracy, precision, linearity, LOD, LOQ and were found to be within the limits. It can be concluded that these two methods could be successfully used for the simultaneous estimation of Spironolactone and Furosemide in bulk and combined tablet dosage forms.
Abstract
The intent of the present work was to develop a simple, sensitive, accurate, precise, rapid and economical UV- spectrophotometric and reverse phase high pressure liquid chromatographic method for the simultaneous estimation of Spironolactone and Furosemide in bulk and combined tablet dosage forms. UVSpectrophotometry was carried out by simultaneous equation method using 0.02 M potassium dihydrogen phosphate buffer pH 3.5: Acetonitrile (50:50) v/v as a solvent. The linearity range was 2-14 μg mL−1 for Spironolactone and Furosemide with a correlation coefficient > 0.99. The chromatographic separation was achieved on 250 mm × 4.6 mm, hypersil BDS C18 column with particle size 5 μm, by using an isocratic mixture of 0.02 M potassium dihydrogen phosphate buffer pH 3.5: Acetonitrile: tert butyl methyl ether (49:50:1) v/v/v as a solvent at a flow rate of 1 mL min−1 and UV detection was carried out at 254 nm. The retention time were observed to be 3.666 and 6.661 minutes for Furosemide and Spironolactone respectively. The two developed methods were validated according to the ICH guidelines for accuracy, precision, linearity, LOD, LOQ and were found to be within the limits. It can be concluded that these two methods could be successfully used for the simultaneous estimation of Spironolactone and Furosemide in bulk and combined tablet dosage forms.
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