Desenvolvimento e valida??o de método analítico para determina??o do teor de sinvastatina em cápsulas magistrais

摘要

Simvastatin is an oral anti-hyperlipidemic that has been widely used to reduce the cardiovascular disease risk. There isn't any pharmacopoeic method to assay this drug in capsules. It was proposed and validated a method for determining the content of simvastatin in capsules by UV/visible spectrophotometry (l = 237 nm), a more affordable method for the compounding pharmacy. The method was validated for linearity, specificity, range, accuracy, precision, performance, robustness, and limits of detection and quantification.