DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR QUANTITATIVE DETERMINATION OF RELATED SUBSTANCES PRESENT IN ELETRIPTAN HYDROBROMIDE DRUG SUBSTANCEAbstract
An efficient and sensitive RP-HPLC method was developed and validated for the estimation of related substances in Eletriptan hydrobromide drug substance which were identified and characterized by LCMS, FTIR, 1HNMR, 13CNMR techniques. The method was carried out on a Purosphere STAR RP-8e column at temperature 20°C using a phosphate buffer at pH 4.0 and solvent mixture consists of acetonitrile, water and tetrahydrofuran in the ratio of 70:30:1v/v/v in gradient mode of pump. The flow rate is 1.5 ml/min and detection was done at 225nm.The developed RP HPLC method was validated by testing specificity, precision, detection limit, quantification limit, linearity, accuracy, robustness and range. The linearity of the method was confirmed over the range of 0.09 to1.4µg/ml for related substances with correlation coefficients greater than r = 0.999. The accuracy of the method was found to be 98.6 to 102.3% and RSD as found to be less than 2.0% indicating high degree of accuracy and precision for the proposed method. The effective recovery and lower %RSD prove the highness of the proposed RP HPLC method for the routine determination of Eletriptan hydrobromide related substances in drug substance.
M. V. Dalawai *, S. Nallapati, J. K. Vundavilli, P. K. S.R. Kothapalli , U. K. Ray , P. D. Sanasi, P. Rajput and H. K. Sharma
Aurobindo Pharma Limited Research Centre-II, Indrakaran village, Sangareddy mandal, Medak district, Andhra Pradesh, India
04 August, 2014
15 October, 2014
27 December, 2014
01 April, 2015