Study of Degradation Behavior of Active Pharmaceutical Ingredients

Abstract

Stability testing of drugs is mandated by regulatory body as well as health agencies of various newlinecountries across the globe. Since it will ensure quality of drug product throughout its shelf newlinelife. Hence by considering influence of stability on quality of drug it was endeavored to study newlinedegradation behavior of selected drugs. newlineA comprehensive study of the stress degradation behavior of atorvastatin (ATR) and aspirin newline(ASP) was carried out in accordance with ICH guidelines, alone as well as in combination of newline1:1 and 1:7.5 ratios, respectively. The degradation products of ASP as well as atorvastatin newlinewere successfully separated by a developed simple, selective, and precise stability-indicating newlinereversed-phase HPLC method. The extent of degradation was significantly influenced when newlineboth of the drugs were present in combination. In addition the combination ratio of aspirin newlineand atorvastatin also influenced the percentage degradation of each other. All the results newlineindicate chemical incompatibility of both aspirin and atorvastatin if present in combination. newlineA novel, simple, isocratic as well as LC-MS compatible RP-HPLC stability indicating assay newlinemethod for tapentadol hydrochloride (TAP) was developed and validated. Forced degradation newlineof TAP was carried out in accordance with ICH guidelines. TAP found stable under all forced newlinedegradation conditions, except oxidative stress. TAP showed two major degradation products newlinein oxidative stress condition. Furthermore both oxidative degradation products were newlinecharacterized with the help of LC-MS/MS technique. Furthermore its fragmentation pathway newlineand plausible mechanism for generation of degradation product was also proposed. No newlineprevious report was available in the literature regarding the characterization of degradation newlineproduct of TAP. newlineA new, simple, isocratic as well as LC-MS compatible RP-HPLC stability indicating assay newlinemethod was developed and validated for febuxostat (FBX) in bulk as well as in its newlinepharmaceutical dosage form. FBX was found unstable under alkaline hydrolytic c