Determination of linagliptin and dapagliflozin propanediol monohydrate by high-performance liquid chromatography in pharmaceutical forms

A simple, sensitive, precise, rapid, and cost-effective High-Performance Liquid Chromatographic (HPLC) method was developed for the separation and quantification of Linagliptin (LIN) and Dapagliflozin Propanediol Monohydrate (DPM) in TABLE t dosage forms. The separation was achieved using a C18 column (150×4.6 mm, five μm), with a mobile phase of concentrated phosphoric acid (pH adjusted to 4) and acetonitrile in a 50:50 %v/v ratio. The flow rate was 1.0 ml/min, and injection volume was 20 µl. Detection was performed using UV detector at 280 nm, with retention times of 1.630 minutes for LIN and 2.971 minutes for DPM. The method demonstrated linearity for LIN and DPM in concentration ranges of 0.5–15 µg/ml and 1–20 µg/ml, with R² values of 0.9993 and 0.9995, respectively. Validation of the method, performed per ICH guidelines, confirmed its linearity, precision, accuracy, specificity, robustness, ruggedness, limit of detection, and limit of quantitation. All validation parameters were within accepTABLE limits. The method was successfully applied to estimate the two drugs in their pharmaceutical formulations.