A validated reverse phase LC-MS method for quantification of drotaverine in biological matrices

A simple and precise liquid chromatography coupled with mass spectrometry LC-MS method was developed for determination and quantification of Drotaverine in human plasma and validated. The drug was separated by using liquid – liquid extraction (LLE) Method. A C18 column was employed for the separation of the drug on a gradient mode by using high-performance liquid chromatography (HPLC). The lower limit of quantification (LLOQ) of Drotaverine was 1.013ng/mL. The calibration curve ranges from of 0.993ng/mL to 498.245ng/mL with desirable linearity and r2 greater than 0.99. The intra-day accuracy was within 100.583–98.033% with coefficient of variation 0.90–0.14%. No significant interference observed by endogenous peak at the retention time of Drotaverine and IS. The assay was free from any matrix effect, precise recovery across the calibration curve range and samples were stable under all experimental conditions.