HPLC method development for determination of glyoxal content in ondansetron HCL drug substances by derivatization with 2,4 DNPH

摘要

A simple, sensitive, and reproducible stability-indicating high-performance liquid chromatography method was developed for the analysis of glyoxal content in ondansetron HCl by derivatization technique. Chromatographic separation was achieved on symmetry shield RP18 (250 mm length, 4.6 mm inner diameter with 5m with a mobile phase consisting of a mixture of monobasic potassium phosphate and acetonitrile and pH adjusted to 3.0 with orthophosphoric acid (95:5 v/v) as mobile phase A, and acetonitrile, methanol, and water (85:5:10 v/v/v) as mobile phase B. UV detection was performed at 385 nm, the flow rate was 1.0 mL/min, and the column oven temperature was maintained at 30 癈. The high correlation coefficient (r 2 0.999) values indicated clear correlations between the investigated compound concentrations and their peak areas within the test ranges. The repeatability and intermediate precision, expressed by the RSD, were less than 2.0%. The accuracy of the method was further ascertained by performing recovery studies via a spike method. The high recovery and low relative standard deviation confirm the suitability of the method for routine quantification of glyoxal content in ondansetron HCl. The method was validated according to the present ICH guidelines for, limit of detection, limit of quantification, linearity, accuracy, precision, ruggedness, and robustness.