A simple, selective, accurate High Performance Liquid Chromatographic (HPLC) method was developed and validated for the analysis of Fenspiride hydrochloride in bulk and tablet dosage forms. Chromatographic separation was achieved isocratically using a C18 reverse phase column [Inertsil C18 column (250×4.6mm, 5μm)] utilizing a mobile phase containing 10mM Ammonium acetate: Acetonitrile (50:50 v/v) at a flow rate of 1 mL/min. The eluents were monitored at wavelength of 210 nm for a run time of 7 minutes at ambient temperature. The average retention time of the drug was found to be 4.6 minutes. The developed method was validated as per ICH guidelines to ascertain the reproducibility of the method. The method was found to be linear in the concentration range of 10-50 μg/mL with a good correlation coefficient of 0.998. The limit of detection (LOD) and limit of quantification (LOQ) were 0.007 and 0.021 μg/mL and the percentage recovery and assay were found to be 99.315 and 98.97%. Specificity with placebo by 3 D plots showed that the method was specific and free from interfering substances. Therefore, the fully validated method was good enough to carry out routine analysis of Fenspiride in bulk and tablet formulations.
A simple and precise RP-HPLC method was developed and validated for the determination of opipramol hydrochloride in pharmaceutical dosage forms. Chromatography was carried out on Inertsil column(250 x 4.6mm, 5μm) using a mobile phase of acetonitrile: 10mM ammonium acetate (65:35% V/V) at a flow rate of 1.2mL/min. The analyte was monitored using UV detector at 254 nm. The retention time was found to be at 5.572 min for opipramol hydrochloride. The proposed method was found to be linear in the concentration range of 10-35 μg/mL with correlation coefficient of 0.998. The mean recoveries obtained for opipramol hydrochloride were in the range of 100.23-101.81%. Limit of Detection (LOD) and Limit of Quantification (LOQ) were found to be 0.00842 and 0.0255 μg/mL, respectively. The developed method has been statistically validated according to ICH guidelines and found to be simple, precise, and accurate with the prescribed values. Thus the proposed method was successfully applied for the estimation of opipramol hydrochloride in routine quality control analysis in bulk and its formulations.
The analytical method was developed and validated for determination of acyclovir in ointment by High performance liquid chromatography. The separation was carried out on Luna C18 column (250 × 4.6mm × 5µ). The mobile phase consists of water: acetonitrile in the ratio 88:12 at flow rate 0.8ml/min with diode array detector wavelength at 254nm.The column temperature was adjusted at 30ºC±40ºC with injection volume 20µl.The retention time of acyclovir was 4.747min. The linearity of the calibration curve was linear over the concentration range 80-120µg/ml (r2=0.9996). The validation was carried out as per ICH guidelines. The development method was easy, rapid, linear, precise, accurate and consistent.
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