A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF PSEUDOEPHEDRINE

Y. Rajendra Prasad

Volume 14, Issue 03 2024

Abstract:

A new simple, precise, selective, accurate and rapid reverse phase high performance liquid chromatographic stability indicating method had been developed and validated for simultaneous quantitative determination of Pseudoephedrine, Ambroxol and Desloratidine in bulk and pharmaceutical dosage form. The chromatographic separation was achieved with InertisilODS 3V, (250×4.6 mm) and 5 µm particle size column. The optimized mobile phase consisting of phosphate buffer: Acetonitrile: Methanol (50:20:30 %v/v). The flow rate was 1.0 mL/min and eluents were detected at 225 nm using PDA detector. The retention time of Pseudoephedrine, Ambroxol and Desloratidine were found to be 2.379, 3.971 and 5.450 respectively. The percentage recoveries for three molecules were found to be in the range of 99-102%. The calibration curve was constructed between peak area vs concentration and demonstrated good linearity in the range of 2.5 -15 μg/ml for Pseudoephedrine, 30-180 μg/ml for Ambroxol and 2.5-15 μg/ml for Desloratidine. Degradation studies were studied for Pseudoephedrine, Ambroxol and Desloratidine under various stress conditions such as acid hydrolysis, base hydrolysis, oxidation, thermal, photochemical and UV. All the degradation peaks were resolved effectively using developed method with different retention times. The developed method was validated according to ICH Q2-R1 guidelines. As the method could effectively separates the degradation products from active ingredients, it can be used for routine analysis of drug both in bulk and pharmaceutical dosage form.

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