Research Article
Vidya V Gawande and Anil Chand
Abstract
validated HPLC-DAD method had been developed for combined synthetic mixture of Aspirin (AS) and Omeprazole (OME). The analytes were separated using C18 Water Xterra (50 × 4.6 mm id, particle size 3.5μm) as stationary phase with mobile phase composition water (containing 0.1% Triethylamine pH adjusted to 2.47 ± 0.03 with Orthophosphoric acid): Methanol (50:50% v/v). The Flow rate was 1.2 ml/min opting isocratic mode with runtime of 7 min. and the analytes were detected at 244 nm. The average retention time for both the analytes was found to be 0.89 ± 0.37 min and 4.28 ± 1.91 min for AS and OME respectively. As the Indian market still lacked the selected finished dosage form (YOSPRALA); the laboratory synthetic mixture was prepared and directly compressed into tablets and then analysed successfully using proposed method. The% of label claim for both the drugs was obtained nearly 100 ± % RSD <2. ICH guidelines were followed to validate the method. The method assured linearity for 50-150% of labelled claim for both the analytes. The method assured high degree of precision and accuracy. The method was proved to be robust by assessing robustness parameters.