ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF TENELIGLIPTIN IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC
M. Vijaya Kumari*, P. Eswaramma, Ch. Nageswar Rao, V. Veena Sravani, B. Thirupathamma, K. Praveen, P. Lokesh.
ABSTRACT
A simple, rapid, precise and accurate Gradient reversed-phase HPLC method was developed and validated for the determination of Teneligliptin in commercial tablets. Separation was achieved on a C8, 150x4.6mm i.d., 5μm stainless steel analytical column i.e. using a mobile phase A consisting of 1ml OPA in 1000ml water and Acetonitrile: Methanol (80:20)v/v as mobile phase B with pH 5.3 at a flow rate of 1.0ml/min and UV detection at 213nm. The retention time was found to be 9.8min.The linearity of the proposed method was investigated in the range of 48.6-148.9μg/ml (r2 = 0.999). The percent amount of drug estimated by all developed methods was nearly 100%, found to be in good agreement with label claim of marketed tablet formulation. The recovery study was carried out at three different levels and results were found to be satisfactory. The validation parameters like accuracy, precision, ruggedness, linearity and range were studied for all the developed methods and were found to be within limits. It can be conveniently adopted for routine quality control analysis of Bulk and pharmaceutical formulations.
Keywords: Tenelegliptin, RP-HPLC, Validation.
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