IDENTIFICATION AND QUANTIFICATION OF LINAGLIPTIN IN PHARMACEUTICAL PREPARATION BY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY
Suraj Sahoo*, Suman Kumar Mekap, Monalisa Mahapatra, Rasmita Jena and Deepak Sarangi
ABSTRACT
A high performance liquid chromatography (HPLC) procedure was
developed for Linagliptin, a dipeptidyl peptidase-4 inhibitor. The
present work is optimised to develop simple, economic procedure
which is linear, precise, accurate and robust. Identification was
executed by HPLC using mobile phase that consist of 0.1 % percholric
acid, acetonitrile and methanol in the ratio of 65:35:10 v/v at a flow
rate of 1.2 ml/min with detection at 235 nm by Ultraviolet detector.
The retention time noted is 3.7 minutes. Linearity results with
correlation coefficient value of 0.999 to get calibration curve holds
good agreement between different concentration levels and detector
response. The % RSD values under precision obtained for method
precision and intermediate precision are 0.3 and 0.5 respectively. There exists a good
agreement among amount recovered (99.6 -100.4%) at different levels. The % RSD values
obtained for robustness under change in organic solvent, flow rate detection and wavelength
are 0.8, 0.2 and 0.7 respectively. The validation results obtained are within the acceptance
criteria laid down by ICH. The present procedure can be applied for the identification of
Linagliptin in tablet dosage form in routine laboratory works.
Keywords: Linagliptin, HPLC, Ultraviolet, Validation, ICH.
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