The evaluation and application of UPLC for the rapid analysis of dose formulations

The use of Ultra Performance Liquid Chromatography (UPLC) with UV and MS detection was evaluated in several pharmaceutical applications. Initial studies characterized the commercial instrumentation performance parameters for isocratic and gradient separations as a function of flow rate using several commercially available drugs as model probe compounds. Parameters examined included reproducibility of retention time and peak area, as well as theoretical plates, resolution, and column ruggedness. The use of high-speed separations for dose formulation strength analysis was evaluated using two model drug compounds: mefenamic acid and chloramphenicol, in a dimethylacetamide/polyethyleneglycol-200 vehicle. Accuracy, precision, and resolution were examined under high-speed gradient conditions for the dose formulation analysis.