Stability Indicating Rp-Uplc-Dad Method For Determination Of Metformin And Canagliflozin In Bulk And Tablet Dosage Form
INTERNATIONAL JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH(2020)
Abstract
The objective of the present work is to develop and validate a novel stability-indicating RP-UPLC-DAD method for the simultaneous analysis of Metformin and Canagliflozin in bulk and tablet dosage form. The chromatographic separation was accomplished on a Waters UPLC system equipped with autosampler and PDA detector. A volume of 5 mu L of sample or standard was injected into the column and the analytes were separated by using the mobile phase containing mixture of 0.1% orthophosphoric acid buffer (pH adjusted to 3.0 with 0.1 N NaOH) and acetonitrile in the ratio 30:70% v/v at a flow rate of 0.25ml/min through C18 BEH (Ethylene Bridged Hybrid) UPLC (100 mm x 2.1 mm 1.7 mu m) at 55 degrees C column temperature and the detector wavelength was set at 260 nm. Peak area and retention time of Metformin and Canagliflozin were found to be 651341 & 332544, 0.994 & 1.508 respectively. Regression analysis shows r value greater than 0.999 for Metformin and Canagliflozin. Percent recovery of Metformin and Canagliflozin was found to be 99.94 %-100.16% & 100.17%-100.68%, respectively. The developed RP-UPLC method was validated with regard to system suitability, linearity, robustness, accuracy, precision, LOD, LOQ and forced degradation studies.
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Key words
Forced degradation, Metformin, Canagliflozin, RP-UPLC, Stability - indicating and Validation
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