Simultaneous Method Development for Pseudoephedrine Hydrochloride and Desloratadine
Abstract
Introduction: Chromatographic techniques are primarily used for the qualitative and quantitative analysis of pharmaceutical compounds, drug formulations, and raw materials throughout the drug development process, from the early research phase to the final release of therapeutic products. Objective: Simple, accurate, economical and reproducible RP-HPLC method for simultaneous estimation of two component drug mixture pseudoephedrine hydrochloride and desloratadine in combined tablet dosage form. Material and methods: Developed HPLC method is reversed phase chromatographic method using inertsil C18 column and methanol: ammonium acetate buffer in ratio of 70:30 pH 6.5 adjusted with sodium hydroxide, as mobile phase at a flow rate of 1.0ml/ min. The developed method was validated in terms of specificity, linearity, precision, intermediate precision, accuracy, robustness and solution stability. Results: The linearity was observed in concentration range of 12.5-37.5 ug/ml of desloratadine and 450-1350 ug/ml of pseudoephedrine hydrochloride. The results are validated statistically and by recovery studies. The proposed RP-HPLC method achieved satisfactory resolution between desloratadine and pseudoephedrine hydrochloride. It can be used for the synthetic process control and determination of desloratadine in drug substance and pharmaceutical preparation. Conclusion: Quality is paramount in all products and services; a 'regulatory analytical technique' is used to evaluate a distinguishing attribute of raw materials, active pharmaceutical ingredients, and pharmaceutical formulations within the pharmaceutical industry. This method is suitable for routine quality control and stability testing of pseudoephedrine hydrochloride and desloratadine in pharmaceutical formulations.
Keywords: RP-HPLC, Simultaneous estimation, Method development, Pseudoephedrine hydrochloride, Desloratadine
Keywords:
RP-HPLC, Simultaneous estimation, Method development, Pseudoephedrine hydrochloride, DesloratadineDOI
https://doi.org/10.22270/jddt.v15i6.7157References
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