World Journal of
Pharmaceutical and Life Sciences

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical and Life Sciences
An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)
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Abstract

DEVELOPMENT OF ANALYTICAL METHOD FOR THE DETERMINATION OF LINAGLIPTIN IN BULK DRUG AND ITS PHARMACEUTICAL FORMULATION

Dr. R. Xavier Arulappa*, M. Jerubin Welsingh, Athira S. S., Ameena N. S., Amina S., Layana Valsan, Roshinee R and Dr. G. R. Prasobh

ABSTRACT

Analytical method development and validation is important in development of pharmaceutical preparations. The aim of the present work was to develop and validate a simple UV spectroscopic method for the determination of Linagliptin in pharmaceutical dosage form. The UV spectrum of Linagliptin in ethanol showed λ max at 290 nm. Beer’s law obeyed in the concentration of 10-50mcg/ml. This method was carried out according to ICH Q2R1 guidelines by taking the parameters for linearity, accuracy, precision, ruggedness and robustness. The method was rugged and robustness with % relative standard deviation less than 2. The extraction recovery was found to be higher than 98% in all experimental conditions. Based upon the performance characteristics, the proposed method was found accurate, precise and rapid and suitable for the determination of Linagliptin for routine analysis.

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