ABSTRACT:
The fixed-dose combination of linagliptin and empagliflozin for the treatment of type 2 diabetes mellitus is increasingly being used in clinical practice. Consequently, there is a need for stability studies and routine quality control testing of the drug product, which requires the development of a simple, reliable, and stability-indicating analytical method. This research was aimed to develop, optimize and validate the simultaneous determination of two compounds Linagliptin and Empagliflozin in their bulk and pharmaceutical tablet dosage form using reverse phase high-performance liquid chromatography (RP-HPLC) with ICH Q2(R2) criteria. The separation was performed by HPLC on a C18 column with mobile phase methanol/0.1% orthophosphoric acid (30:70 v/v) at 0.7mL/min flow rate at 235nm UV. The developed method was validated in terms of system suitability, linearity, accuracy, precision, repeatability, sensitivity, ruggedness, robustness, assay and forced degradation studies. The linearity of both drugs was good, R² value were 0.9996 within their respective concentration ranges. The method was found to be reliable and reproducible with the recovery value of 99.72-102.17% for Linagliptin, whereas %RSD was found to be below 2% for all the precision studies which indicates the reliability of the method, and found to be below 2% for Empagliflozin which indicates recovery value of 99.29-101.20%. The assay results showed acceptable release of drug from the marketed formulation, while the stress degradation studies under acidic, alkaline, oxidative, neutral and photolytic conditions showed good separation of the drug degradation products from the analytes, proving the stability indicating nature of the method. The developed RP HPLC method is simple, rapid, selective, accurate, economical, and can be used for routine pharmaceutical quality control, stability testing and analysis of combined Linagliptin and Empagliflozin formulation.