Phenylephrine Hydrochloride Tablets

Author(s):  
Mayuresh Kiran ◽  
Lalit Pawaskar ◽  
Shaheen Sheikh ◽  
Pramita Waghambare

Introduction: Common cold is frequently occurring medical condition in developing countries like India. Common cold is self-limiting in nature so symptomatic treatment is always suggested. This study was conducted to test the efficacy and safety for the fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet for the treatment of common cold. Methodology: Total 180 patients were enrolled out of which 159 completed the study. Efficacy assessment was done by decrease in total symptom score (TSS) of common cold at day 3 and 5 as compared to the baseline (day 1). Safety assessment was made by analyzing the reported adverse events through the study. Results: Mean TSS at baseline was 6.62 which was decreased to 3.55 at day 3 and was further decreased to 0.68 at day 5. Majority of patients had complete relief from the symptoms of common cold and nearly all the patients had >50 % reduction in TSS. Also no unexpected or serious adverse event was found to be reported in the study duration of 5 days. Conclusion:  Fixed dose combination of Paracetamol 500 mg, Phenylephrine Hydrochloride 10 mg and Chlorpheniramine Maleate 2 mg per tablet was found to be efficacious and safe for the symptomatic treatment of common cold in Indian patients. Keywords: Common cold, Paracetamol, Chlorpheniramine Maleate and Phenylephrine


2015 ◽  
Vol 12 (1) ◽  
pp. 167-177 ◽  
Author(s):  
Baghdad Science Journal

A spectrophotometric method has been proposed for the determination of two drugs containing phenol group [phenylephrine hydrochloride (PHP) and salbutamol sulphate (SLB)] in pharmaceutical dosage forms. The method is based on the diazotization reaction of metoclopramide hydrochloride (MCP) and coupling of the diazotized reagent with drugs in alkaline medium to give intense orange colored product (?max at 470 nm for each of PHP and SLB). Variable parameters such as temperature, reaction time and concentration of the reactants have been analyzed and optimized. Under the proposed optimum condition, Beer’s law was obeyed in the concentration range of 1-32 and 1-14 ?g mL-1 for PHP and SLB, respectively. The limit of detection (LOD) and limit of quantification (LOQ) for each of PHP and SLB were 0.60, 0.52 ?g mL-1 and 2.02, 1.72 ?g mL-1, respectively. No interference was observed from common excipients present in pharmaceutical preparations. The good correlation coefficients and low relative standard deviation assert the applicability of this method. The suggested method was further applied for the determinations of drugs in commercial pharmaceutical preparations, which was compared statistically with reference methods by means of t- test and F- test and were found not to differ significantly at 95% confidence level. The procedure was characterized by its simplicity with accuracy and precision.


2008 ◽  
Vol 27 (2) ◽  
pp. 149 ◽  
Author(s):  
Ivana Savić ◽  
Goran Nikolić ◽  
Vladimir Banković

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 μg⋅cm−3 (r2 = 0.9990) in the sodium hydroxide medium. The apparent molar absorptivity was found to be 1.63×103 dm3⋅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 μg⋅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.


1965 ◽  
Vol 48 (3) ◽  
pp. 579-582
Author(s):  
William R Clark ◽  
Lynn A Rosenberg

Abstract determination of phenylephrine hydrochloride in combination with other amine-type drugs. The mixture is placed on a sodium borate-Celite column and the nonphenolic amines are removed with chloroform. The phenylephrine remaining on the column is acetylated and removed with a chloroform wash. The acetylated phenylephrine is then saponified with alcoholic KOH and determined spectrophotometrically against standard phenylephrine at about 290 mμ. Recoveries averaged 98.5% with a range of 93.3–101.7%. Mean deviation from the average was 1.8%. The method was adopted as official, first action.


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