Objective: A simple and accurate stability indicating reversed-phase high-performance liquid chromatography method was developed and validated for the simultaneous estimation of phenylephrine and fexofenadine in pharmaceutical dosage forms.Methods: Chromatography was carried out on an Kromasil C-18 column (4.6 mm×250 mm, 5 µ particle size) with a isocratic mobile phase composed of ortho phosphoric acid buffer, acetonitrile, (75:25% v/v) at a flow rate of 1 mL/minutes. The column temperature was maintained at 30°C and the detection was carried out using a photodiode array detector at 210 nm.
Results:The retention times for phenylephrine and fexofenadine were 2.156 minutes and 3.359 minutes, respectively. The percentage recoveries of phenylephrine and fexofenadine were 100.63% and 99.84%, respectively. The relative standard deviation for assay of tablets was found to be <2%. The detection and quantification limits were found to be 0.10 and 0.31 µg/mL for phenylephrine and 0.01 and 0.03 µg/mL for fexofenadine, respectively.
Conclusion:Thus, the method was fast, accurate, precise, and sensitive; hence, it can be employed for routine quality control of tablets containing both drugs in quality control laboratories and pharmaceutical industries.
A selective, rapid and sensitive method was developed for the determination of genotoxic impurities (2-Amino-6-chloro purine and Bromo compound) in Penciclovir drug substance using RPUPLC-MS/MS. The chromatographic separation was performed on Kromasil C8 column (150 mm x 4.6 mm, 5 μm) maintained at 45°C using 0.1%formic acids in water as buffer and acetonitrile through gradient programme. The flow rate was maintained at 0.5mL/min with an injection volume of 10 μL. For the quantification of genotoxic impurities, positive-electrospray ionisation (ESI) mode was selected. Penciclovir and its impurities were well separated within the shortest run time of 16min. The chromatographic method was developed, and the results of all validation parameters showed that the technique is well confined to the limits of ICH guidelines. The method has high sensitivity, and the limit of detection was found to be as low as 0.15 and 0.30 ppm for 2-Amino-6-chloro purine and Bromo compound. The recovery of 2-Amino-6-chloro purine and Bromo compound are found in the range of 80-120%. The linearity of peak area versus concentration was demonstrated in the range of LOQ - 150% level of impurities with a correlation coefficient of 0.9999. The method has proved too robust by introducing minuscule changes in the chromatographic parameters. The method was successfully validated and applied for Penciclovir drug substances and their dosage forms to determine the mentioned genotoxic impurities.
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