JOURNAL 1734
Journal of Chemical Metrology
Year: 2020 Issue: 2 July-December
p.125 - 132
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Dimalkumar A Shah
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Ishita Gondalia
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Vandana Patel
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Ashok Mahajan
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Usmangani K. Chhalotiya
GRAPHICAL ABSTRACT
ABSTRACT
Accurate and precise reverse phase liquid chromatographic method has been developed for the estimation Remogliflozin etabonate in bulk and tablet dosage form. Reverse phase C18 column was used as stationary phase along with mixture of methanol:water (70:30%, v/v) as a mobile phase. Mobile phase flow rate was maintained at 1mL/min and analysis was performed at 229 nm. The method was linear in the concentration range of 1 – 25 μg/mL with correlation coefficient (r2) 0.997. The proposed method was validated with respect to linearity, accuracy, precision and robustness as per ICH Q2 (R1) guideline. To find out the possible degradation pathway, forced degradation studies were performed. The degraded product peaks were well resolved from the pure drug peak with significant difference in their retention time value. The drug was found to be highly susceptible to acid and base hydrolysis. The developed method can be used for analysis of stability samples and routing quality control evaluation of Remogliflozin etabonate in tablet formulation.
KEYWORDS- Forced Degradation
- validation
- remogliflozin
- liquid chromatography
