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Title: Development and validation of ultraperformance liquid chromatography (UP-LC) method for estimation of a new anti-diabetic drug linagliptin in bulk and its tablet formulation
Authors: Dubey, Nidhi
Singh, G N
Tyagi, Anchal
Bhardwaj, Rakesh
Raghav, C S
Keywords: UPLC;Method development;Validation;Linagliptin;DPP-4 inhibitor;Type II diabetes
Issue Date: Aug-2014
Publisher: NISCAIR-CSIR, India
Abstract: A simple, precise and accurate isocratic reversed-phase ultra performance liquid chromatography (UP-LC) method has been developed and validated for determination of linagliptin in bulk and its pharmaceutical formulation. Isocratic separation has been achieved on an Agilent SB-C18 RRHD (50 mm × 2.1 mm, 1.8 μm) column using mobile phase of 0.01 M potassium phosphate H 4.0 and acetonitrile (30:70) at a flow rate of 0.3 mL per min. The injection volume is 2.0 μL and the detection has been carried out at 292 nm by using photo-diode array detector. The method has been validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness and ruggedness. The method is linear in the drug concentration range of 0.5-100 μg/mL with a correlation coefficient of 0.9998. The accuracy (recovery) is between 97.81% and 100.51%. The proposed method offers significant advantages over the reported methods, as the former is more sensitive and selective, has a short analysis time i.e. 5.0 min. (Rt for linagliptin is 1.5 min), good accuracy and precision, having the LOD and LOQ value 0.25 μg/mL and 0.5 μg/mL.
Page(s): 1136-1139
ISSN: 0975-0983(Online); 0376-4699(Print)
Appears in Collections:IJC-B Vol.53B(08) [August 2014]

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