A simple, accurate, precise, economical method was developed for the simultaneous estimation of the Ebastine and Montelukast in tablet dosage form by the RP-HPLC method. The chromatogram was run through Kromosil (250mm x 4.6 mm, 5m.) The mobile phase containing potassium dihydrogen phosphate buffer and Acetonitrile was taken in the ratio 60:40 was pumped through the column at a flow rate of 1ml/min. The pH was adjusted to 4.8 with Orthophosphoric acid. A buffer used in this method was potassium dihydrogen phosphate solution. The temperature was maintained at 30°C. The optimized wavelength for Ebastine and Montelukast was 244nm. The retention time of Ebastine and Montelukast were found to be 2.447 min and 3.436 min respectively. With the optimized chromatographic conditions, the drug was linear in the concentration range of 0 -150 μg/ ml. The correlation coefficient was found to be 0.999. The average percentage assay in the formulation was found to be 99.05% and 99.20% for Ebastine and Montelukast respectively. % Recovery for Ebastine and Montelukast was found to be 99.93% and 99.69% respectively. %RSD for repeatability was found to be 0.2 respectively. LOD, LOQ values are obtained from regression equations of Ebastine and Montelukast were 0.11ppm, 0.33ppm and 0.14ppm, 0.43ppm respectively. Regression equation of Ebastine is y = 19263x+1149, and y = 19946x+1095 of Montelukast. Hence the suggested RP-HPLC method can be used for routine analysis of Ebastine and Montelukast in API and Pharmaceutical dosage form.
A simple, accurate, rapid and precise method was developed for the simultaneous estimation of Ibuprofen and Diphenhydramine in Pharmaceutical dosage form. Chromatogram was run through Inertsil ODS (250x4.6mm) 5µ. Mobile phase used was Acetonitrile and Phosphate buffer (45:55) at a flow rate of 1.0 ml/min and detection wavelength was found to be 260 nm. The retention time was found to be 2.32 min and 2.93 min for Ibuprofen and Diphenhydramine respectively. The accuracy and reliability of the method was assessed by evaluation of linearity, precision (intra-day and inter-day % RSD >2), accuracy (98-102%), specificity, LOD, LOQ values in accordance with ICH guidelines. The developed method is applicable for routine quality control analysis of selected combined dosage forms.
A simple, Accurate, precise method was developed and validated for the simultaneous estimation of Epalrestat and Pregabalin in Tablet dosage forms. Chromatogram was run through C8 (250 x 4.6 mm, 5µ) Column. Mobile phase contains Potassium Dihydrogen Phosphate Buffer: Acetonitrile taken in the ratio 45:55 was pumped through column at a flow rate of 1 ml/min. The pH was adjusted to 5.4 with Orthophosphoric acid. Temperature was maintained at 25°C. Optimized wavelength selected was 274 nm. Retention time of Epalrestat and Pregabalin were found to be 2.373 min and 2.967 min. % Relative Standard Deviation of the Epalrestat and Pregabalin were found to be 0.1and 0.3 respectively. % Recovery was obtained as 99.85% and 99.42% for Epalrestat and Pregabalin respectively. Limit of Detection, Limit of Quantification values obtained from regression equations of Epalrestat and Pregabalin were 0.24, 0.73 and 0.02, 0.07 respectively. Regression equation of Epalrestat is y = 26994x + 13337, and y = 24913x + 7779 of Pregabalin. Retention time decreased so that the run time decreased. So the method developed was simple and economical that can be adopted in regular Quality control test in Industries.
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