DEVELOPMENT AND VALIDATION OF SIMPLE EFFECTIVE HPLC METHOD FOR THE QUANTITATIVE DETERMINATION OF RELATED SUBSTANCE PRESENT IN SITAGLIPTIN PHOSPHATE DRUG SUBSTANCE
AbstractAn efficient and sensitive RPHPLC method was developed and validated for the estimation of Sitagliptin Phosphate process impurities in drug substances which were identified and characterized by LCMS, FTIR, 1H NMR, C NMR techniques. The method was carried out on a Symmetry shield RP 18 column at 25°C using a 1 % Perchloric acid and acetonitrile in gradient mode of pump. The flow rate is 1.2 ml/min and detection was done at 210nm.The developed RP HPLC method was validated by testing specificity, precision, Forced degradation, detection limit, quantification limit, linearity ,accuracy, robustness and range. The linearity of the method was confirmed over the range of 0.113 to 3.384µg/ml for Sitagliptin Phosphate impurities with correlation coeffients greater than r=0.999.The accuracy of the method was found to be 98.5 to 101.1% and %RSD as found to be less than 2% indicating high degree of accuracy and precision for the proposed method. The effective recovery and lower RSD proves the highness of the proposed RP HPLC method for the routine determination of Sitagliptin Phosphate impurities in drug substances
Article Information
16
1493-02
631
2106
English
IJPSR
Meher Vijay Dalawai *, Paul Douglas Sanasi and Hemant Kumar Sharma
Aurobindo Pharma Limited Research Centre-II, Indrakaran village, Sangareddy Mandal, Medak district, Andhra Pradesh, India
MeherVijay.Dalawai@aurobindo.com
12 October, 2015
24 November, 2015
16 January, 2016
10.13040/IJPSR.0975-8232.7(4).1493-02
01 April, 2016
Download