HPLC Development and Validation

  Linagliptin frequently associated in pharmaceutical a formulation that reduces blood sugar levels in patients with type 2 diabetes. Their quantification presents several problems. A HPLC method for the determination of these compounds in pharmaceutical formulations, including the separation of impurities and excipients has been developed and validated. The method was simple, selective, linear, precise and accurate. Isocratic elution at a flow rate of 1ml min-1 was employed on a symmetry C18 column at ambient temperature. The mobile phase consisted of Methanol: Water 83:17(v/v) and pH of the mobile phase was adjusted to 4.1 with 0.1% Orthophosphoric Acid . The UV detection wavelength was at 241nm.Linearity was observed in concentration range of 5-30ppm. The retention time for Linagliptin was 5.85min.The method was validated as per the ICH guidelines. The proposed method can be successfully applied for the estimation of Linagliptin in pharmaceutical dosage forms. Key Words: Linagliptin, HPLC Development and Validation, ICH guidelines.