Assay method demonstrates precision and accuracy for estimating gliclazide and dapagliflozin in tablets, indicating its effectiveness for quality control.
A new simple, rapid, precise and accurate assay method was developed for simultaneous estimation of Gliclazide and Dapagliflozin in pure form and tablet form. The analytes were separated by RP HPLC on a RPPurosnosphere C18 column (5 µm, 4.6mm* 250 mm).The mobile phase was Acetonitrile: water: methanol (10:20:70v/v) at 1.0 ml/min flow rate satisfactorily resolve the tertiary mixture. The UV detector was operated at 234 nm for the determination of all the drugs. Linearity, accuracy and precision were found to be acceptable over the concentration ranges of 15-75 µg/ml for Gliclazide and 5-25 µg/ml for Dapagliflozin with a R2 0.996 and 0.9963 values respectively. The optimized methods proved to be specific, robust and accurate for the quality control of drugs in bulk drug and pharmaceutical formulations.
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Changare et al. (2025) studied this question.
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