APPLICATION OF ION PAIR RP-HPLC METHOD IN PHARMACEUTICAL QUALITY CONTROL DISSOLUTION TESTING FOR SIMULTANEOUS ESTIMATION OF COMBINED TABLET DOSAGE FORMS WITH ACETYLSALICYLIC ACID AND GLYCINE

摘要

The aim of the paper was to present the possibility of applying the novel method (RP-HPLC ion pair method) for the simultaneous dissolution determination of combined tablet dosage form containing acetylsali-cylic acid and glycine in pharmaceutical industry. The samples were gradient eluted using a Pursuit XS Ultra C18 column (150 x 3.0 mm, with a particle size of 2.8 μm) with variable composition of mobile phase A (1-heptanesulfonic acid sodium salt aqueous solution (2.8 g/L), pH 2.2 ± 0.05 adjusted with orthophosphoric acid) and phase B (methanol). The detection was carried out at 210 nm with a constant flow rate of 0.4 mL/min. The method was validated by determining precision (repeatability and intermediate precision), accuracy, specificity, linearity, range, system suitability, robustness and stability in accordance with ICH guidelines. The method was accurate, precise and linear within the range of 0.03 - 0.18 mg/mL for acetylsalicylic acid and 0.016-0.096 mg/mL for glycine. The method is simple, convenient and suitable for analyzing acetylsalicylic acid and glycine in pharmaceutical formulations. The method could also be used for routine assay determination after small modification of sample preparation.