Volume : 13, Issue : 01, January – 2026

Title:

A NEW SIMPLE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF MIRABEGRON AND SOLIFENACIN SUCCINATE IN BULK FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM DOSAGE FORM

Authors :

K. Vanitha Prakash*, B. Gouri Shankar Chary

Abstract :

A novel, simple, specific, accurate, precise method development and validated for the simultaneous estimation of Mirabegron and Solifenacin Succinate by RP-HPLC in bulk and marketed formulation. A High-Performance Liquid Chromatography WATERS Alliance 2695 separation module, Software: Empower 2, 996 PDA Detector with Phenomenex Luna C18, 100A, 5µm, 250mmx4.6mm i.d. column, with mobile phase composition of Acetonitrile and Buffer pH-3.4 with OPA were taken in the ratio of 55:45% v/v/v was used. The flow rate of 1.0 ml min-1 and effluent was detected at 330 nm. The retention times of Mirabegron and Solifenacin Succinate were 2.285 and 3.135 minutes. Linearity was observed over the concentration range of 6-14µg/ml and 10µg/ml-30µg/ml for Mirabegron and Solifenacin Succinate respectively. The Limit of detection and limit of quantification of Mirabegron and Solifenacin Succinate were found to be 0.09ng ml-1 and 0.29ngml-1 & 0.1ng ml-1 and 0.3ngml-1 respectively. The accuracy of the proposed method was determined by recovery studies and found to be 98% to 102%. The method was validated in terms of linearity, accuracy, precision, (repeatability, intermediate precision) specificity (by assay), robustness, and system suitability. Thus, the validated method can be successfully applied to routine analysis to regulate the quality. It also should be used for analytical research purposes.
Keywords: Mirabegron and Solifenacin Succinate, RP-HPLC, Method Development, Validation.

Cite This Article:

Please cite this article in press K. Vanitha Prakash et al., A New Simple Analytical Method Development And Validation For The Rp-Hplc Method For Simultaneous Determination Of Mirabegron And Solifenacin Succinate In Bulk Form And Marketed Pharmaceutical Dosage Form Dosage Form, Indo Am. J. P. Sci, 2026; 13(01).

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