A stability-indicating RP-HPLC method was developed and validated for the estimation of empagliflozin drug and its tablet dosage form using a DAD detector. The mobile phase consisted of methanol/acetonitrile/0.1%OPA (75:20:5). The peak was observed at 2.54 min using 222.0 nm absorption maxima. Calibration curve plot was found within the range of 10–50 µg/mL. The coefficient of determination (R2) was found to be 0.9990. Forced degradation studies were performed for the empagliflozin in various conditions, and the results were calculated as %RSD values and were found to be within the limits. The method was validated as per ICH guidelines with respect to all validation parameters.

中文翻译：

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用于测定恩格列净的稳定性指示 HPLC-DAD 方法

开发并验证了稳定性指示 RP-HPLC 方法，用于使用 DAD 检测器估计恩格列净药物及其片剂剂型。流动相由甲醇/乙腈/0.1% OPA (75:20:5) 组成。使用 222.0 nm 吸收最大值在 2.54 分钟处观察到峰值。在 10–50 µg/mL 的范围内发现了校准曲线图。确定系数 (R2) 为 0.9990。在各种条件下对恩格列净进行了强制降解研究，结果计算为 %RSD 值，发现在限值内。该方法根据 ICH 指南对所有验证参数进行了验证。