Validated Bivariate Calibration Spectrophotometric and High Performance Liquid Chromatographic Methods for Simultaneous Determination of Dantrolene Sodium and Paracetamol in Pharmaceutical Dosage Form

摘要

Two simple and sensitive methods were developed for simultaneous determination of dantrolene sodium and paracetamol without previous separation. The first method is a bivariate calibration algorithm involving the use of data from four linear regression calibration equations, two calibrations for each component at two selected wavelengths; 250 nm and 290 nm. The second method describes the use of high performance liquid chromatography (HPLC), in which separation was performed using reversed phase C₁₈ column and a mobile phase composed of methanol: potassium dihydrogen phosphate (50:50 v/v) adjusted to pH 3.5 by phosphoric acid, with flow rate of 1 ml min^-1 and UV detection at 380 nm for dantrolene sodium and 248 nm for paracetamol. Beer’s law was obeyed in the concentration range of 1-16 and 1-15 μg mL^-1 for dantrolene sodium and paracetamol respectively by bivariate method. While the linearity ranges was found to be 0.5-15 and 2.5-120 μg mL^-1 for dantrolene sodium and paracetamol by HPLC method. The proposed methods were successfully applied for the determination of the two cited drugs in their pharmaceutical preparation with mean recoveries ranging from 99.5 – 100.6+ 0.94 -2.16%. In addition, results were validated as per International Conference on Harmonization (ICH) guidelines.