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Abstract
A simple, isocratic liquid chromatographic method was developed for determination of nelfinavir from its impurities, degradation products, and assay for the first time. This method involves the usage of a C18 (Hypersil BDS C18, 250 mm×4.6 mm, 5 µm) column. The method was validated over the range of LOQ to 120% of impurity specification limit and LOQ to 150% of analyte concentration for assay. The mobile phase consists of the mixture of 50 mM of sodium phosphate buffer, acetonitrile, and methanol in the ratio of 30∶50∶20. The flow rate was set at 1.0 mL/min with UV detection monitored at 220 nm. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis, and thermal degradation. The developed method was validated for linearity, range, precision, accuracy, and specificity. This method can be conveniently used in the quality control laboratory for routine analysis for both the assay and impurities of drug substances, drug products, and also for the evaluation of stability study samples.
Acknowledgment
The authors wish to thank to management of the Matrix group for support of this work. The authors also wish to express their sincere thanks to all colleagues in the process research and quality laboratories for their constant encouragement and support during the period of work carried out.