Stability-Indicating Reversed Phase-HPLC Method Development and Validation for Estimation of Phenylephrine in Bulk and Tablet

Abstract:

Background: This study is aimed to develop a validated stability-indicating method of a nasal decongestant phenylephrine hydrochloride in bulk and tablet. Materials and Methods: A sensitive, accurate, and specific reversed-phase stability indicating HPLC method was developed and validated by following ICH guidelines, for the estimation of Phenylephrine Hydrochloride (PHE) in bulk and tablet. On Luna® 5μm C₁₈ column (250 × 4.6mm), the isocratic separation was achieved using mobile phase of 5mM ammonium acetate (pH 4.7): methanol (80:20; v/v) with a flow rate of 1 mL/min and a column temperature at 30°C. The proposed method was able to produce good separation of the drug and its degradation products with sharp peaks. The quantification was done at 272 nm by photodiode array detection. Conclusion: It was discovered that the phenylephrine hydrochloride was resilient to photolytic and thermal degradation, but degraded under acid, base, and oxidative stress conditions. The developed method was found to be linear, robust, and accurate and can be successfully applied for identification, quantitative determination, and monitoring of the stability of phenylephrine in bulk and tablet dosage forms.

Keywords: Chromatogram, High performance liquid chromatography, Decongestant, Degradation, ICH guidelines.