An Advanced Study on Development and Validation of RP-HPLC Method for Simultaneous Estimation of Mesalamine and Prednisolone in Bulk and Formulation

Abstract

In accordance with the analytical parameter mentioned in the ICH guidelines, a simple, precise, accurate, sensitive, and economical reversed phase high performance liquid chromatographic method was developed and validated for the simultaneous determination of Mesalamine (MSL) and Prednisolone (PRD) in combined dosage forms The medicines were separated by chromatography on a C-18 Phenomenex column (250 mm 4.6 mm i.d.) with a mobile phase of acetonitrile: phosphate buffer (pH adjusted to 6 with Orthophosphoric acid) (20:80 v/v). The detection was done at a wavelength of 330 nm. Mesalamine and Prednisolone had retention durations of 4.373 minutes and 1.589 minutes, respectively. Linearity was established for Meselamine in the range of 5-25 \(\mu\)g/ml and Prednisolone in the range of 2-10 \(\mu\)g/ml. Mesalamine and Prednisolone were shown to have 99.57 percent and 100.63 percent recovery rates, respectively. Correlation coefficient of Mesalamine was found to be 0.9973 and for Prednisolone it is 0.9984. The method showed adequate precision with smaller RSD (less than 1%).