Review on simultaneous estimation of fixed dose combinations (FDC): system suitability testing (SST) parameters of RP-HPLC analysis

Abstract

This study presents the system suitability criteria for the assessment of multiple fixed dose combinations using reversed - phase chromatography. RP-HPLC is a separation technique based on the lipophilic interaction between the solute molecules in the mobile phase and the aromatic ligand. System suitability tests are utilized to confirm that a chromatographic system is suitable for independent analysis. The assay of combinational oral dosage forms using RP-HPLC was studied in this review. The objective was to determine the compliance of the assays in existing literature meets SST characteristics established by the USP recommendation. If the characteristics were not met, the cause was identified and a possible solution was proposed. Twelve articles were identified as part of this research. Reviewing the system suitability testing (SST) parameters as per USP guideline suggested, reflects any potential lack of knowledge part in of method development in developing robust methods.