BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENELIGLIPTIN HYDROBROMIDE HYDRATE
Shailesh V. Luhar*, Jahnvi V. Desai, Dr. G.K. Jani and Dr. P. Malairajan
ABSTRACT
To develop simple, accurate, precise, sensitive and rapid LC-MS method for the quantification of Teneligliptin in human plasma using Repaglinide as internal standard (IS). In LC-MS, estimation of Teneligliptin was carried out by using Waters Acquity UPLC system, using a Hypersil Gold C18 column (50 mm×3.0 mm, 1.9 μm; Thermo scientific, India) and with mobile phase 0.1% formic acid in Milli-Q water: Acetonitrile (20:80), at a flow rate of 0.5 ml/min with injection volume was 2 μL. The total chromatographic run time was 5.50 min. The analytes and IS were extracted by Solid Phase Extraction Technique. Retention time of Teneligliptin and Repaglinide was found to be 3.98 and 3.72 min. The quantification of Teneligliptin was performed in a positive electro spray ionization mode and multiple reactions monitoring (MRM) the m/z value obtained for Teneligliptin is 427.2→243.2 and for Repaglinide is 453.2→ 230.2. LC-MS method was found to be linear over the range of 1-1000 μg/ml for Teneligliptin with r2>0.998. The method has been validated for linearity, accuracy and precision, recovery, matrix effect and Dilution integrity and stability.
Keywords: Teneligliptin, LC-MS, Bioanalytical Method, validation.
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