Published Article

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF LINAGLIPTIN IN TABLET DOSAGE FORM

Authors

Authors: Sammi Akter, Fahim Shahrier Rahman, Bidduth Kumar Sarkar, Arghya Prosun Sarkar, Md. Al Azad, Apurbo Kumer Saha, Taslima Akter, Sukalyan Kumar Kundu*

Abstract

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.

Keywords

Linagliptin Tablet HPLC Method Validation potency Column.