Forced Degradation Study Of Selective H1Antihistaminic Drugs In Bulk And Formulation

Abstract

quotThe research study demonstrates development and validation of stability indicating HPLC methods for H1-Antihistaminic Drugs (Bilastine, Ebastine and Azelastine), degradation kinetic study; and identification of degradation products of selected drugs by LC-MS/MS study. Moreover, Literature review revealed that reported analytical methods are not adequate to monitor degradation kinetics and to demonstrate the degradation pattern of the drugs in various stress conditions. To estimate selected drugs stability indicating HPLC methods were developed and validated as per ICH guideline. Then they were extended to study degradation kinetics of drugs with different temperatures. newlineFurther degradation products were identified by LC-MS/MS data. The developed HPLC methods are accurate, precise, simple, sensitive and stability indicating and are suitable for routine analysis of drugs in their formulations. Order of degradation reaction was found. LC-MS/MS data confirms that in presence of hydrochloric acid, Bilastine reacts with methanol and produced methyl ester of Bilastine and on reaction with hydrogen peroxide Bilastine produces N-oxide of bilastine. LC-MS/MS study reveals that hydrochloric acid does the hydrolysis at ether linkage of Ebastine and Ebastine reacts with oxidizing agent, hydrogen peroxide and produces N-oxide of Ebastine. newlineThis PhD thesis would be useful for providing HPLC methods for routine analysis of selected drugs and they can be extended for bio-analysis of drugs.quot newline newline