STABILITY INDICATING REVERSED PHASE-HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS DETERMINATION OF RELATED SUBSTANCES OF CITICOLINE AND PIRACETAM IN PHARMACEUTICAL DOSAGE FORM

摘要

Objective: A high-performance liquid chromatography (HPLC) method was developed and validated to determine stability indicating method ofPiracetam and Citicoline in a tablet dosage.Methods: The separation was made using Inertsil C18, 250 × 4.6 mm, 5 μm column, mobile phase used contained phosphate buffer and acetonitrilein the gradient mode at wavelength of 205 nm for Piracetam and 280 nm for Citicoline on a PDA detector.Results: The method showed good linearity for, respectively related substances of Citicoline and Piracetam with correlation coefficients in the rangeof 0.29-623 μg/mL and 0.48-1030 μg/mL, respectively. Method accuracy was assessed at three levels; the recovery ranged between 100.0% and 102%for Citicoline and for Piracetam between 94.3% and 109.1%. Limit of detection and quantification for Citicoline was 0.07 μg/mL - 0.25 μg/ml and forPiracetam 0.12 μg/mL - 0.41 μg/ml. The solution was found to be stable within 27 hrs at room temperature.Conclusion: The method was demonstrated to be robust and simple, and suitable for industrial application for determination of related substancesin the pharmaceutical preparation.