Development and Validation of New Analytical Methods and Their Applications for Analysis of Beta Adrenergic Blockers

Abstract

Aim: Simple, precise, accurate, robust, rapid and economical analytical methods were developed for the determination of Beta Adrenergic Blockers and its combination in a pharmaceutical formulation.Results and Discussion: Simultaneous estimation of various selected Betaadrenergic blockers and its combination i.e. Nebivolol and newlineHydrochlorothiazide, Nebivolol and Indapamide, Carvedilol and Ivabradine, Timolol maleate and Brimonidine tartrate had been carried out by the developing the UV spectroscopic methods and RP-HPLC 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 constituents for the estimation of TIM and BRM. From the results, major degradation was found in acid and alkali degradation, which further evaluated using LC-MS study to check the interference of the degradents with respect to analyte peaks. newline newlineConclusions: The proposed developed methods for selected Beta adrenergic blockers and its combination i.e. Nebivolol and Hydrochlorothiazide, Nebivolol and Indapamide, Carvedilol and Ivabradine, Timolol maleate and Brimonidine tartrate were successfully validated as per ICH Q2 (R1) and from the results it was concluded that the present method may be use for the routine estimation of the raw materials and in the pharmaceutical formulation. newline