SULFONIC ACID COUNTER IONS QUANTIFICATION IN PHARMACEUTICALS BY ION CHROMATOGRAPHYAbstract
The present paper deals with the analysis of methane sulfonic acid, benzene sulfonic acid and camphor sulfonic acid counter anions in pharmaceutical ingredients (doxazosin mesylate, amlodipine besylate and clopidogrel camphor sulfonate) by suppressed conductivity anion chromatography. The diluent used for the preparation of sample solution was Milli-Q Water and injected into a standard chromatographic system connected with 250 mm length, 4.0 mm ID, 5.0 µm particle size, Metrosep A Supp1 column and suppressed conductivity detector. The developed analytical method was highly precise and accurate compared to titration methods and HPLC-UV detection methods to analyze counter ions in drug substance. Calibration curves were linear with correlation coefficient of > 0.999 for anions. The % RSD of area response of anions in standard injections was below 2.0, which demonstrates the method precision of the test procedure. The accuracy of the method was also studied and observed between 97% and 102%. The developed method was validated according to ICH guidelines for the quantitative determination of anions in API taken for the study.
K. Yarbagi *, B.Srikanth, Venkatesh Pilli, J. Moses Babu, B. Venkateswara Rao and Paul Douglas
Analytical Research, Custom Pharmaceutical Services, Dr. Reddy’s Laboratories Ltd., Bollaram road, Miyapur, Hyderabad-500049 (AP), India
28 October, 2015
22 December, 2016
22 January, 2016
01 April, 2016