ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LINAGLIPTIN IN TABLET DOSAGE FORM

A specific, accurate, precise, linear and cost effective HPLC method wasdeveloped for estimation of Linagliptin. Separation of the Linagliptin wasachieved on a Column C18 (250 mm x 4.6 mm, 5 μm) Xterra @ RP 18 issuitable, using a mobile phase consisting of a mixture of 50 volumes ofbuffer solution and 50 volumes of methanol (v/v). The flow rate was1mL/min and detection wavelength was 293 nm. The linearity was found inthe concentration of 0.0075, 0.0125, 0.0200, 0.0250, 0.0375, mg/mL with acorrelation coefficient (R2) of 0.999. The retention time of Linagliptin was5.58 minutes. The predicted method was validated as per the InternationalConference for Harmonization guidelines for the parameters: Linearity,Accuracy, Robustness, Precision, Specificity etc. This method can be usedfor routine analysis of quality control of Linagliptin in tablet dosage form.