A Rapid, sensitive and economical high performance liquid chromatographic method for determination of Linagliptin has been developed. The chromatography system containing reverse phase C18 Column (250×4.6mm, 5µm) with a mixture of Methanol: Water in a ratio of 40:60 with flow rate of 1.0 ml min-1. OPA was used as buffer to maintain the pH 3 of mobile phase. UV detector was used at 238 nm and 20µl sample was injected. The method was validated as per ICH guideline. The retention time of Linagliptin was found to be 7.3 min. The calibration curve is linear in the range of 2-10 µg/ml. The percentage RSD for precision and accuracy of method was found to be less than 2 %. The lower limit of detection (LOD) and limit of quantification (LOQ) was 0.015 and 0.04 ppm respectively. Recovery studies from tablet were between 98.76, 100.88, and 101.98%. The method can be successfully used for routine analysis of Linagliptin form tablets formulation.
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