ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LINAGLIPTIN IN TABLET DOSAGE FORM
Sammi Akter, Fahim Shahrier Rahman, Bidduth Kumar Sarkar, Arghya Prosun Sarkar, Md. Al Azad, Apurbo Kumer Saha, Taslima Akter and Sukalyan Kumar Kundu*
A specific, accurate, precise, linear and cost effective HPLC method was developed for estimation of Linagliptin. Separation of the Linagliptin was achieved on a Column C18 (250 mm x 4.6 mm, 5 μm) Xterra @ RP 18 is suitable, using a mobile phase consisting of a mixture of 50 volumes of buffer solution and 50 volumes of methanol (v/v). The flow rate was 1mL/min and detection wavelength was 293 nm. The linearity was found in the concentration of 0.0075, 0.0125, 0.0200, 0.0250, 0.0375, mg/mL with a correlation coefficient (R2) of 0.999. The retention time of Linagliptin was 5.58 minutes. The predicted method was validated as per the International Conference for Harmonization guidelines for the parameters: Linearity, Accuracy, Robustness, Precision, Specificity etc. This method can be used for routine analysis of quality control of Linagliptin in tablet dosage form.
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