Stability Indicating Method Development and Validation of Metoprolol Succinate and Empagliflozin by RP-HPLC in Synthetic Mixture
Abstract
This review article focuses on the development and validation of a stability-indicating RP-HPLC method for the
simultaneous estimation of Metoprolol Succinate and Empagliflozin in a synthetic mixture. The analytical technique plays a
vital role in the pharmaceutical quality control process, ensuring accuracy, precision, and reproducibility of analytical data. The
method was developed using a C18 column with a suitable mobile phase composition, flow rate, and detection wavelength
optimized for maximum resolution. Forced degradation studies were performed under various stress conditions such as acidic,
alkaline, oxidative, thermal, and photolytic to ensure the method’s stability-indicating nature. The proposed method was
validated according to ICH Q2(R2) guidelines for parameters such as linearity, accuracy, precision, specificity, robustness, limit
of detection, and quantitation. The method was found suitable for routine analysis of combined dosage forms of Metoprolol
Succinate and Empagliflozin
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