ABSTRACT

A novel simple, precise, accurate and validated, liquid chromatography-tandem mass spectroscopy method has been developed for the quantitative determination of midodrine hydrochloride from a commercially available formulation. Caffeine was used as the internal standard. Isocratic separation was achieved using jones C18 column (4.6 x 150mm, 3μm) as a stationary phase and the mobile phase consistsed of 10mM ammonium formate (pH 4.0): methanol (30:70 v/v) with a flow of 0.5 ml/min. Detection was carried out in positive ionization with a mass transitions of 255→237.1 and 195→138.1 to monitor Midodrine hydrochloride and caffeine. The method was found to be linear over a concentration range of 0.30 – 110 ng/ml with a regression analysis of 0.9991. The percentage recovery in the present method was found to be 99.5 ± 1.20. The LC-MS/MS method was validated as per ICH guidelines.