ESTIMATION OF ANTI-DIABETIC TENELIGLIPTIN HYDROBROMIDE HYDRATE BY RP-HPLC AND DERIVATIVE SPECTROSCOPIC METHOD

2016-08-09T05-51-53Z
Source: Indo American Journal of Pharmaceutical Research
Sohan S. Chitlange*, Diptee G. Rawat, Sneha Chandani.
Simple, accurate, precise and economical HPLC and UV method has been developed and validated for the estimation of teneligliptin hydrobromide hydrate (THH) in bulk and tablet dosage form. Isocratic elution at the flow rate of 1.0 ml/min was employed on a Kromasil 100-5-C8 column at ambient temperature. The mobile phase consisted of Methanol: 0.025M phosphate buffer pH adjusted to 3 with o-phosphoric acid (60:40 v/v). The detection wavelength was at 254nm. Linearity was observed in the concentration range of 10-100 μg/ml. The retention time for Teneligliptin was 4.14 min. In stability testing, teneligliptin was found susceptible to alkali hydrolysis and oxidatative degradation. Because the method could effectively separate the drug from its degradation products, it can be used as a stability indicating method. First order derivative UV spectrophotometric method was also developed using methanol as solvent at analytical λ 261.0 nm. Beers law was obeyed in the concentration range of 5-50 μg/ml and r2 =0.9996. The proposed methods were validated according to the ICH guidelines. Both the developed methods are accurate and precise and can be used for routine quality control analysis of Teneligliptin in bulk and pharmaceutical formulation. In case of HPLC as well resolved peak is obtained for Teneligliptin after degradation, method is also suitable for stability studies.


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