DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RELATED SUBSTANCE METHOD FOR ACETAZOLAMIDE TABLETS

Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RELATED SUBSTANCE METHOD FOR ACETAZOLAMIDE TABLETS Patel Suresh*, Dr. Omray Lavakesh, Soni Pushpendra Radharaman Institute of Pharmaceutical Sciences, Bhopal, Madhya Pradesh, India ABSTRACT Acetazolamide is the prototype of new class of antiepileptic drugs. Drugs which is carbonic anhydrase inhibitors used in mainly as an antiepileptic. The present work deals with development and validation of related substance method development through stability indicating of acetazolamide tablets, an adequate simple, precise, selective, economic High performance liquid chromatographic method has been developed then validated for identification and analysis purpose. Reversed phase chromatography was performed on a C-18 column with Phosphate buffer and acetonitrile in the ratio as mobile phase with a flow rate 1.0 ml/minute. 265nm wavelength shown adequate peak shape and height at retention time approximately 7.8 minutes. The % RSD of peak area response of acetazolamide in LOQ level concentrated shown less than 2%. The chromatographic method was validated in many parameters such as specificity, accuracy, precision, robustness, reproducibility according to ICH guidelines. Statistically found that method was qualify with all validation parameters on acetazolamide tablets. This method was suitable for routine analysis because proved that wide linearity range covered, sensitive, shorter retention time, simple mobile phase as well Keywords: Acetazolamide, RP-HPLC, Anti-epileptic drugs. Full Text Article