Senthilkumar GP
Publications by Senthilkumar GP
3 publications found • Active 2016-2020
2020
1 publicationDevelopment and Validation of HPLC Method for Determination of Degradation Impurities for the Qualification of Mebevrine HCl
Reverse phase high performance liquid chromatographic method for the estimation degradation impurities of Mebeverine HCl in bulk drug is illustrated. The method consists of; Mobile phase B: Acetonitrile and Mobile phase A: 0.051 M Phosphate buffer (pH-4.5) in gradient pump mode. A linear response was observed in the range of 0.8 to 48 µg/ml with a regression coefficient of 0.999 for both Mebeverine HCl and Veratric acid. The force degradation study was performed to determine the degradation pathways which also proves the specificity of the method. The method is cost effective as well as sensitive. Validation parameters were carried out as per the guidelines of International Conference for Harmonization.
2017
1 publicationDevelopment and Validation of Noscapine In Bulk and Pharmaceutical Formulations by RP-HPLC Method
A simple, specific, quick, isocratic Reversed Phase High Performance Liquid Chromatographic method was developed and validated for the analysis of Noscapine. RP-HPLC method was developed on a Symmetry C-8 (4.6 × 150 mm), 3.5 µm particle, reversed-phase column. The mobile phase was 0.1% octane sulphonic acid (pH- 3): acetonitrile, 40:60 (v/v) at a flow rate of 0.8 ml/min. and the eluate was monitored at 260 nm. The retention time of the drug was found to be 2.314 min. The method was linear over the range of 4-8 μg/ml with a regression coefficient of 0.999 and validated with respect to accuracy, precision, linearity, and specificity, limit of detection and limit of quantization as per the guidelines of International Conference for Harmonization (ICH). This method can be used in the industries for determination of Noscapine to analyze the quality of formulation without interference of the excipients.
2016
1 publicationMethod Development and Validation of Clobazam In Bulk and Pharmaceutical Dosage Forms by Using RP-HPLC Method
Clobazam is an antiepileptic drug. There have been very less number of analytical methods developed for estimation of Clobazam in pure bulk form and in dosage form. In the present research a simple, accurate, precise and cost effective High performance liquid chromatographic method for the estimation of Clobazam, in bulk and pharmaceutical dosage form was carried out. HPLC method was developed on a Symmetry C-8 (4.6×150mm), 3.5µm particle, reversed-phase column. The mobile phase was acetonitrile: phosphate buffer (0.05M, pH- 4.5), 60:40 (v/v) at a flow rate of 0.8ml/min. The eluate was monitored at 231 nm. The method was validated reaching satisfactory results for selectivity, precision and accuracy. The retention time of the drug was found to be 3.38min in the mobile phase, acetonitrile: 0.05M potassium dihydrogen orthophosphate buffer (pH-4.5) 40: 60 (v/v). A linear response was observed in the range of 20-60µg/ml with a regression coefficient of 0.999. Validation parameters were carried out as per the guidelines of International Conference for Harmonization (ICH). This method can be used in the industries for determination of Clobazam to analyze the quality of formulation without interference of the excipients.
