Development and validation of RP-UHPLC procedure for estimation of 5-amino salicyclic acid in 5-amino salicyclic acid rectal suppositories

[摘要] The present study describes a simple and robust reverse phase ultra performance liquid chromatography (RP-UPLC) method for the quantification of 5-amino salicyclic acid in 5-amino salicyclic acid rectal capsules. Successful separation of Mesalamine peak from excipient peaks and diluent were achieved on a Acquity C8 (50 × 2.1 mm, 1.7 μm) and UV detector at 254 nm, 0.3 mL/min as a flow rate, and 3 μL as an injection volume. For the RP-UPLC method, phosphate buffer and methanol was used as mobile phases at ratio of 83:17 and the column temperature was 25 °C. Percentage recovery obtained in the range of 98.7-99.7 % and the method is linear for Mesalamine for specified concentration range with coefficient of variation (r) not less than 0.99. The proposed RP-UPLC method was found to be specific, linear, precise, accurate and robust.

[发布机构] Department of Chemistry, School of Advanced Sciences, VIT University, Vellore-14, Tamil Nadu, India^1

[效力级别] 工业技术

[关键词] Coefficient of variation;Column temperature;Concentration ranges;Injection volume;Percentage recovery;Phosphate buffers;Salicyclic acids;Ultra performance liquid chromatography