DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR PHENYLEPHRINE HYDROCHLORIDE ESTIMATION IN NASAL DROPS FORMULATIONS

Simple, accurate and reproducible UV-spectrophotometric method was developed and validated for the estimation of phenylephrine hydrochloride in pharmaceutical nasal drops formulations. Phenylephrine hydrochloride was estimated at 291 nm in 1 mol.dm(-3) sodium hydroxide (pH 13.5). Beer's law was obeyed in the concentration range of 10-100 mu g.cm(-3) (r(2) = 0.9990) in the sodium hydroxide medium. The apparent molar absorptivity was found to be 1.63 x 10(3) dm(3).mol(-1).cm(-1). The method was tested and validated for various parameters according to the ICH (International Conference on Harmonization) guidelines. The detection and quantitation limits were found to be 0.892 and 2.969 mu g.cm(-3), respectively. The proposed method was successfully applied for the determination of phenylephrine hydrochloride in pharmaceutical nasal drops formulations. The results demonstrated that the procedure is accurate, precise and reproducible (relative standard deviation < 1 %), while being simple, cheap and less time consuming, and hence can be suitably applied for the estimation of phenylephrine hydrochloride in different dosage forms.