DEVELOPMENT AND VALIDATION OF VISIBLE SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF PHENYLEPHRINE HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORM
Keywords:Phenylephrine Hydrochloride, Folin-Ciocalteu, Chromogen, Visible Spectrophotometric, Validation
A simple, sensitive, precise, accurate, economic and rapid visible spectrophotometric method has been developed and
validated for estimation of Phenylephrine Hydrochloride using Folin-Ciocalteu (F.C.) reagent in presence of 10% Sodium
Carbonate solution. The blue colour chromogen formed is measured at wavelength of maximum absorption 749 nm
against reagent blank. The chromogen showed linearity in the concentration range of 2-16 ?g/ml for Phenylephrine
Hydrochloride. The optimum parameters for maximum absorbance were found to be 2.0 ml, 3.5 ml and 15 minutes for F.C. reagent, 10% Sodium Carbonate solution and time, respectively. The method was validated for linearity, precision, accuracy, limit of detection (LOD) and limit of quantification (LOQ) as per ICH guidelines. The percentage RSD values obtained were 0.96 - 1.44 and 0.82 – 1.39 for interday and intraday precision, respectively. The average percent recovery was found to be 101.05 ± 0.67 for proposed method. The assay results obtained was 101.10 ± 0.59 for Phenylephrine Hydrochloride using proposed method. The proposed method was found to be simple economic and sensitive, hence can be used for the routine analysis and quality control checking of Phenylephrine Hydrochloride in pharmaceutical dosage form.
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