Development and validation of spectrophotometric and chromatographic analytical methods for agents used in secondary cardiac prophylaxis

Abstract

Aim: Simple, precise, accurate, robust, rapid and economical spectrophotometric as well as chromatographic analytical methods were developed for the determination of aspirin and Omeprazole in a pharmaceutical formulation. newline newlineMaterial and Methods: Yosprala, the fixed dose combination of aspirin and Omeprazole was selected and raw materials were procured from the well-known sources. Analytical methods. i.e. Reverse Phase HPLC by applying AQbD approach, HPTLC and FTIR Spectrophotometry have been developed and validated according to the ICH Q2 (R1) guidelines. Also, forced degradation study was conducted for the aspirin and Omeprazole. newline newlineResults and Discussion: Simultaneous estimation of aspirin and Omeprazole had been carried out by the developing RP-HPLC, HPTLC as well as FTIR spectrophotometric method. After successful completion of method development, validation of developed methods was performed as per the ICH Q2 (R1) guideline and the results for Linearity, Precision, LOD and LOQ, Accuracy, Robustness, System suitability study and assay of Pharmaceutical dosage forms were well within the predefined acceptance criteria. Forced degradation study was performed to ensure the possible interference of degradents in the presence of active Pharmaceutical constituents for the estimation of Aspirin and Omeprazole. From the results, major degradation was found in acid and alkali degradation. newline newlineConclusion: The proposed developed methods for aspirin and Omeprazole newlineWere successfully validated as per ICH Q2 (R1) and from the results it was concluded that the present method may be used for the routine estimation of the raw materials and in the pharmaceutical formulation. newline