A simple, specific, accurate, rapid, inexpensive isocratic Reversed Phase-High Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Itopride HCl in pharmaceutical tablet dosage forms. RP-HPLC method was developed by using Welchrom C18Column (4.6 X 250mm, 5µm), Shimadzu LC-20AT Prominence Liquid Chromatograph. The mobile phase composed of 10mM Phosphate buffer (pH-3.0, adjusted with triethylamine): acetonitrile (50:50v/v). The flow rate was set to 1.0 mL.min-1 with the responses measured at 235nm using Shimadzu SPD-20A Prominence UV-Vis detector. The retention time of Itopride HCl was found to be 2.650 min. Linearity was established for Itopride HCl in the range of 2-10 µg.mL-1 with correlation coefficient 0.9999. The validation of the developed method was carried out for specificity, linearity, precision, accuracy, robustness, limit of detection, limit of quantitation. The developed method can be used for routine quality control analysis of Itopride HCl in pharmaceutical tablet dosage form.
A reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for simultaneous estimation of levamisole and albendazole in drug substance and in its combinational dosage form. The analysis was carried out using Inertsil ODS C18 (4.6 x 150 mm, 5 μm) column, and the separation was carried out using a mobile phase containing a buffer of pH 3.5 and acetonitrile (70:30 v/v) pumped at a flow rate of 1.0 mL/min with variable wavelength UV-detection at 224 nm. Both the drugs were well resolved in the stationary phase and the retention times were 2.350 min and 4.055 for levamisole and albendazole, respectively. The method was validated and shown to be linear in the concentration range of 15-45μg/ml and 40-120μg/ml for levamisole and albendazole, respectively. The limit of detection (LOD) and limit of quantification (LOQ) were determined based on standard deviation of the y-intercept and the slope of the calibration curve. LOD and LOQ values were 2.08μg/ml and 6.03μg/ml for levamisole and 3.15μg/ml and 10.40μg/ml for albendazole, respectively. The accuracy of the method was assessed by adding known amount of standard solution (75 %, 100 %, and 125% of the sample concentration) to the preanalyzed sample solution of 100% concentration. All the samples were prepared and analyzed in triplicate. The percentage mean recovery by standard addition experiments of levamisole and albendazole is 99.66% and 98.73%, respectively.
A fast, sensitive, and reliable RP-HPLC method involving cyberlab HPLC System with PDA detection was developed and validated for the quantification of Aclidinium bromide and Formoterol fumarate in inhalation preparations. Chromatography was performed on the Inertsil -ODS C18 (250 x 4.6mm, 5μ) column using filtered and mixed degassed methanol: buffer (75:25 v/v) as a mobile phase with a flow rate of 1.0mL/min and the column effluent was monitored at 240nm. Retention times for Aclidinium bromide 4.713min and Formoterol fumarate 6.691min. The method obeyed linearity in the concentration range of 20-80µg/mL for the two drugs when validated according to standard procedures.
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