RP-HPLC METHOD DEVELOPMENT & VALIDATION FOR SIMULTANEOUS ESTIMATION OF TRITHIOPARAMETHOXYPHENYL PROPANE (ANETHOLE TRITHIONE) AND CHLORPHENIRAMINE MALEATE IN TABLET DOSAGE FORM
Journal Title: Int J of Pharm Res & Analy - Year 2016, Vol 6, Issue 1
Abstract
ABSTRACT A Simple, precise and rapid RP-HPLC method was developed and validated for simultaneous Estimation of Trithiparamethoxyphenyl propene (Anetholetrithione) and Chlorpheniramine Maleate in tablet dosage form. Separation was achieved on Phenomenex Luna C18 (250mm × 4.6 mm, 5 μm) using an isocratic mobile phase Consisting of Acetonitrile and Mixture of 0.1% Ortho phosphoric acid & 0.1% triethylamine in water, (80:20,v/v). The analysis was performed at a flow rate of 1.0 ml / min. Detection was done by UV absorbance at 232 nm and the runtime was 8.0 minutes within which the compounds were separated. The retention time for Chlorpheniramine maleate and Anetholetrithione were found to be 2.42 min and 5.51 min respectively. The method was linear in the range of 20-100 μg/ml (r2 = 0.9976) and 5-25 μg/ml (r2 = 0.9988) for Anetholetrithione and Chlorpheniramine maleate respectively. The method was validated as per ICH guideline with respect to system suitability, Specificity, Linearity, accuracy, precision and robustness. Accuracy was assessed by the standard addition method. The recoveries were obtained in range of 99.56 -101.46% and 99.22-101.87% for CPM and ATT respectively. The repeatability was determined and %RSD for CPM and ATT were found to be 0.66% and 0.41% respectively. The intraday precision was determined and %RSD for CPM and ATT were found to 0.28-0.39% and 0.17-0.49 % respectively. The interday precision was determined and %RSD for CPM and ATT were found to be 0.34-0.73% and 0.54-0.75% respectively. The LOD and LOQ value for CPM was found to be 0.14 and 0.13μg/ml. Keywords: Anetholetrithione, Chlorpheniramine maleate, Hepasulfol-AA® tablets, RP-HPLC.
Authors and Affiliations
Dave Parth A*, Patel Ajay I, Vyas Amit J, Patel Ashok B, Chauhan Vipula B
Keywords
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