Zeitschrift für Chromatographie und Trenntechniken
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Simultaneous, Stability Indicating Method Development and Validation for Related Compounds of Ibuprofen and Paracetamol Tablets by RP-HPLC Method

Gnana Raja M, Geetha G and Sangaranarayanan A

A simple, precise, accurate, simultaneous and stability-indicating RPLC method developed with an effective resolution for active pharmaceutical ingredients and marketed drug products. This method effectively separate all the related substances of Ibuprofen and Paracetamol along with impurities. This method is using in the estimation assay of Ibuprofen and paracetamol in drug substance also. The method was developed using RP18 Embedded polar phase column. A mobile phase used in this method was a mixture of acetonitrile and 0.1% v/v orthophosphoric acid in 55:45 v/v ratio. At 230 nm compounds will eluted and monitored. Ibuprofen and Paracetamol was subjected to the stress conditions of acid, base, oxidative, thermal and photolytic degradation. The degradation products were well resolved from main peak and its impurities, proving the stability-indicating ability of the method. The developed method was validated as per USP and International Conference on Harmonization (ICH) guidelines. The current method has proven good linearity and accuracy over the range of all known impurities from LOQ to 150% of the target concentration. The degree of reproducibility as results obtained by deliberate changes in the method parameter and variety of condition has proven the method is robust and rugged.