SIMULTANEOUS ESTIMATION OF PSEUDOEPHEDRINE, AMBROXOL AND DESLORATIDINE IN COMBINED TABLET DOSAGE FORM BY USING RP-HPLC

Abstract

For the simultaneous estimation of Pseudoephedrine, Ambroxol and Desloratidine in combined tablet dosage form, a practical, sensitive RP-HPLC technique has been developed and validated by choosing chromatographic parameters. On Inertsil ODS C18 (250 x 4.6 ID, 5 µm) with mobile phases containing a mixture of Buffer: Acetonitrile and Methanol (45:25:30 %v/v/v), isocratic elution mode was used to separate the drugs Pseudoephedrine, Ambroxol and Desloratidine from their process related substances. With a detection wavelength of 274 nm, the flow rate was set to 1 mL/minute, and the injection volume was set at 10 µL with a 9-minute run time. The developed method's appropriateness was examined and confirmed in accordance with the ICH (Q2 R2) guidelines for studies on specificity, Linearity, Accuracy, Precision, Detection limit, Quantification limit and Robustness. Pseudoephedrine, Ambroxol and Desloratidine had retention times of 2.37 minutes, 3.97 minutes and 5.45 minutes, respectively. For Pseudoephedrine, Ambroxol and Desloratidine, linearity was found in the concentration ranges of 15-90 µg/mL, 30-180 µg/mL and 2.5-15 µg/mL, respectively. For Pseudoephedrine, Ambroxol and Desloratidine, the percentage recoveries ranged from 99.57-100.48%, 99.38-100.39% and 100.14-100.57%, respectively. The method was proven to be useful for determining and validating the presence of Pseudoephedrine, Ambroxol and Desloratidine in combined tablet dosage form.