METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF TRIFLUOPERAZINE AND ISOPROPAMIDE IN TABLET DOSAGE FORM BY RP-HPLC
Journal Title: Int J of Pharm Res & Analy - Year 2014, Vol 4, Issue 8
Abstract
A simple, precise, rapid, specific and accurate reverse phase high performance liquid chromatography method was developed for simultaneous estimation of Trifluoperzine and Isopropamide in pharmaceutical dosage form. Chromatographic separation was performed on Agilent zorbax SB-C18, 4.6 x 250mm, 5micros column, with mobile phase comprising of mixture of buffer (pH 6.0, adjusted with Ortho phosphoric acid, Acetonitrile in the ratio of 80:20v/v), at the flow rate 0.8ml/min. The detection was carried out at 227nm. The retention times of Trifluoperzine and Isopropamide were found to be 2.4 and 3.6mins respectively with a run time of 10mins, theoretical levels for Trifluoperzine and Isopropamide were 5194 and 6738 respectively, with a resolution of 7.6. As per ICH guidelines the method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation, robustness and ruggedness. Linearity of Trifluoperzine and Isopropamide was found in the range of 30-130μg/ml and that for Isopropamide was found to be 150-250μg/ml. The correlation coefficient for Trifluoperzine and Isopropamide were 0.999 and 1 respectively. The LOD values for Trifluoperzine and Isopropamide were 2.963 and 2.9851 respectively. The LOQ values for Trifluoperzine and Isopropamide were and 9.877μg/ml and 9.9502μg/ml respectively. This demonstrates that the developed method is simple, precise, rapid, selective, accurate and reproducible for simultaneous estimation of Trifluoperzine and Isopropamide tablet dosage form.
Authors and Affiliations
Navya sri D* , Ramamohan Reddy T1 , Ajitha A1 , Uma Maheshwara Rao V1
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