RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND LINAGLIPTINE IN PHARMACEUTICAL DOSAGE FORM
Wrushali A. Panchale, Ashish B. Wadekar, Jagdish V. Manwar*, Gunjan P. Malode, Kajal D. Chaudhari and Ravindra L. Bakal
ABSTRACT
RP-HPLC method was developed for simultaneous determination of metformin hydrochloride (MTL) and linagliptine (LNG) in pharmaceutical dosage form. Mobile phase used for separation consisting of mixture of methanol and water (0.05% O-phosphoric acid) in the ratio 50:50 v/v at flow rate of 0.9 mL/min using C8 Primesile column (250mmX 4.6mm) at 238 nm. Injection volume used was 20 ?L and temperature used was ambient. The retention time of MTL and LNG was found to be 2.85 min and 8.49 min, respectively. The linearity range for MTL and LNG observed was 200-1000 ?g/ml and 1-5 ?g/ml, respectively. Method was validated as per ICH guidelines. Validation parameters studied were linearity and range, recovery study, precision, LOD, LOQ and robustness. Data obtained was found to statistically satisfactorily.
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