A RAPID AND SENSITIVE LC-MS/MS ASSAY FOR THE DETERMINATION OF CLOBAZAM IN HUMAN PLASMA USING ELECTRO SPRAY IONIZATION TECHNOLOGYAbstract
A simple, highly sensitive, precise and accurate liquid chromatography tandem mass spectrometry (LC-MS/MS) method was developed for the rapid quantification of clobazam in human plasma samples. The chromatographic separation was achieved with a reverse phase column Reprosil Gold XBD C18 (100 × 3mm, 3µm) and the mobile phase consisted of 10 mM ammonium acetate buffer and 0.1% acetic acid in methanol (15:85, v/v) as eluent by running a linear gradient method. The effluence was ionized by positive electrospray ionization and measured by mass spectrometry. The method was validated with linear calibration curve over a wide dynamic concentration range of 0.501-499.995 ng/mL and the lower limit of quantification was 0.501 ng/mL with good accuracy and precision. The mean extraction recovery of the method was higher than 96.4% and 103.3% for clobazam and IS, respectively. The method was successfully demonstrated for evaluation of bioequivalence study of 10 mg clobazam tablet formulation in 28 healthy Indian male subjects under fasting condition.
S. Christian *, R. Patel and Shivprakash
Department of Chemistry, Municipal Arts & Urban Bank Science College, Mehsana, Gujarat, India.
10 September, 2017
19 November, 2017
21 November, 2017
01 June, 2018