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Development and Validation of Stability Indicating Rp-Uflc Method for The Estimation of Linagliptin in Active Pharmaceutical Ingredients

R. Maruthi, R.S. Chandan, Anand Kumar Tengli

A simple, RP-UFLC method was established for determining Linagliptin in Active Pharmaceutical Ingredients. Linagliptin is a DPP-4 inhibitor developed by BoehringerIngelheim (German Pharmaceutical Company) for treatment of type II diabetes. Linagliptin was approved by the US FDA on 2 May 2011 for treatment of type II diabetes. Linagliptin and their degradation products were separated using C18 column with Acetonitrile: Methanol (50:50 (v/v) as the mobile phase. Detection was performed at 238 nm using a PDA detector and flow rate 1.5 ml/min and retention time was 4.4 min respectively. The method was validated using ICH guidelines and was linear in the range 2-10 μg /ml (r2=0.995) for Linagliptin. The method showed good linearity, accuracy, precision, ruggedness, robustness, and specificity. Good separation of the analytes and their degradation products was achieved using this method. The developed method can be applied successfully for the determination of Linagliptin. The present method was validated with respect to system suitability, accuracy (recovery) precision, linearity, limit of detection (LOD) and limit of quantification (LOQ) and robustness according to the ICH Guidelines.