Development and Validation of Ranitidine Hydrochloride in Human Plasma by Liquid Chromatography Coupled with Mass Spectrometry and Its Application

Objective: A rapid and sensitive bioanalytical method based on liquid chromatography coupled with mass spectrometry detection with positive ion electrospray ionization was developed for the determination of ranitidine hydrochloride in human plasma using clarithromycin as the internal standard. Methods: A simple protein precipitation method was performed using perchloric acid 5%. The analyte and internal standard were subjected to chromatographic analysis on phenomenex C18 column (100×4.6 mm i.d., 5μ) using acetonitrile and water (90:10v/v) as a mobile phase at a flow rate of 0.5 ml/min. A shimadzu 2010A Liquid Chromatographic coupled with mass spectrometry was operated in the selected ion monitoring (SIM) mode. Results: The described method was linear over the range of (0.025 μg/ml to 2.50 μg/ml) (r = 0.997) and the total analysis time for each chromatograph was 3 min. Mean extraction recovery was 87.91% to 92.69%. Sample was stable at room temperature for 6.0hr and at -700C over 4 weeks respectively. Conclusion: The method provides good sensitivity and excellent precision and reproducibility relatively short term analysis and will be useful tool in the pharmacokinetic study of ranitidine hydrochloride in humans.