ABSTRACT
Topiramate is an anticonvulsant used to treat seizures and prevent migraines. The aim of this study was to develop andvalidate a simple and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to quantifyTopiramate in its formulation. Acetonitrile and ammonium acetate were used as a mobile phase (85:15 v/v ratio),and isocratic elution mode was used for separation using Zorbax RP-C18Column (50 mm × 4.6 mm i.d., 5 µ) asa stationary phase. The standard calibration curve ranges from 1 to 1,000 ng/ml with a correlation coefficient of0.9990 (R2). The detection and quantification limits were obtained at 0.5 and 1.0 ng/ml, respectively. The total runtimeof chromatographic separation was found to be 2.0 minutes with a retention time of 1.23 minutes. The percentagerecovery studies were found to be 90.3%–99.3%. The developed method was found to be simple and sensitive and canbe used for the estimation of Topiramate in bulk and its pharmaceutical formulations.
ABSTRACT
The aim of this study is to develop and validate a method that is simple, precise, sensitive, and rapid compared tousing the liquid chromatography–tandem mass spectrometry method for the quantitative determination of Ribavirin(antiviral drug) in its tablet formulation. The development and validation of the method were achieved using a column(Zorbax 50 mm × 4.6 mm × 5 µm) with mobile phase ammonium formate (pH: 7.50): acetonitrile in the ratio (30:70,v/v) with the flow rate of 0.5 ml/min. The retention time for Ribavirin was 1.1 minutes with the total run time of2.5 minutes. The linearity range for Ribavirin was from 2 to 100 ng/ml with a correlation coefficient of 0.9956. Thedetection and quantitation limits of Ribavirin are 0.7 and 2 ng/ml, respectively. The percentage recovery of Ribavirinranged from 94.00% to 98.33%. The percentage relative standard deviation for intraday and interday precision resultswas found to be 0.67%–2.11% and 1.92%–3.11%, respectively. The new method developed for Ribavirin drug wasfound to be rapid, sensitive, selective, and economical. The established method was the evaluation of Ribavirin in itsmarketed formulation (tablet). The values obtained from the analysis were found out to be within the acceptable limitsas per the International Council for Harmonisation (ICH) guidelines.
ABSTRACT
The current study reports on a mass spectrometric method for the quantification of gemfibrozil drug substance in itsformulation. Isocratic method was used for separation with help of Zorbax SB C18 column (4.6 × 50 mm, 3 µm) using atriple quadrupole mass detector in multiple reaction monitoring (MRM) mode and electrospray ionization as ionizationsource. The resulting runtime was found to be 3 minutes and the analyte elutes at 1.201 minutes 10-mM ammoniumformate was adjusted to pH 3.5: methanol (20:80 V/V) was used as mobile phase. Increased sensitivity from selectiveion monitoring (SIM) to MRM resulted in decreased quantitation limit (LOQ) and 0.5 ng/ml as detection limit (LOD).The method was validated in a range of 1–50 ng/ml and a correlation coefficient of 0.999. The method recoverywas found to be in the range of 94.03 % to 100.02 %. The developed method was validated as per the InternationalConference on Harmonisation (ICH) guidelines