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Open Access | Published: 2017 - Issue 2

Development and Validation of a Stability Indicating Analytical Method For Determination of Related Substances By RPHPLC for Solifenacin Succinate in Solifenacin Succinate Tablets Download PDF


Ranjith Reddy, Rahul Sidhaye, Aniruddha V. Sherikar, Meghana Nadre, Muralee Krishna
Abstract

Solifenacin succinate is a competitive muscarinic acetylcholine receptor antagonist. This article describes development and validation for the determination of related substances of Solifenacin succinate in Solifenacin succinate Tablets by using a high performance liquid chromatography. The high performance liquid chromatography resolution was achieved on a Waters Xterra RP-8 250 x 4.6, 5µ, column with a gradient elution at a flow rate of 1.2 mL/min. The detection was performed by a photo diode array Detector. The method was validated in the concentration range of Limit of quantitation to 150% of working concentration. The intra and inter-day precision and accuracy were within Limit. The overall mean recoveries of Solifenacin succinate impurities were in the range of 90.0% to 110.0% for Limit of Quantitation, 50%, 100% and 150%.

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ISSN: 2229-5402

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