ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENILIGLIPTIN IN PHRMACEUTICAL DOSAGE FORM BY RP-HPLC METHOD
Abstract
A reverse phase liquid chromatography (RP-HPLC) method has been developed and
subsequently validated for the determination of Teneligliptin in Bulk and its pharmaceutical
formulation. Separation was achieved with a Zodiac C18 column(250×4.6 mm I.D., 5μm
particle size , methanol: acetonitrile (90:10) v/v as mobile phase at a flow rate of 1.0 ml/min
, pH 5.2 adjusted with 0.10% orthophosphoric acid and the Column temperature was
maintained at 25°C. UV detection was performed at 235 nm and sample temperature was
maintained at 5°C with a run time of 10min . The method is simple, rapid, and selective. The
described method of Teneligliptin is linear over a range of 25 to 150μg/ml with correlation
coefficient of 0.9991 respectively .The method precision for the determination of assay was
below 2.0% RSD. The method enables accurate, precise, and rapid analysis of Teneligliptin .
It can be conveniently adopted for routine quality control analysis of Bulk and
pharmaceutical formulations.
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