Abstract
Purpose: To develop a gradient high performance liquid chromatography (HPLC) method for the simultaneous determination of phenylephrine (PHE) and ibuprofen (IBU) in solid dosage form.Methods: HPLC determination was carried out on an Agilent XDB C-18 column (4.6 x 150mm, 5 μ particle size) with a gradient mobile phase composed of 0.1 % orthophosphoric acid and acetonitrile at a ratio of: 0.01/95/5, 2.5/95/5, 6/10/90, 8/10/90, 8.1/95/5 and 13/95/5 for time (min)/0.1 % orthophosphoric acid (%)/acetonitrile (%) at a flow rate of 1.0 mL/min. Column temperature was maintained at 30 °C and detection was carried out using a photodiode array (PDA) detector at 210 nm. Validation parameters, including system suitability, linearity, precision, accuracy, specificity, limit of detection (LOD), limit of quantification (LOQ), stability of sample and standard stock solutions as well as robustness were obtained as per International Conference on Harmonization (ICH) guidelines. The proposed method was applied to the determination of phenylephrine and ibuprofen in commercial tablets.Results: Retention time for phenylephrine and ibuprofen were 2.7 and 8.4 min, respectively while % recovery was 99.42 and 99.80 %, respectively. The relative standard deviation (% RSD) for assay of the tablets was < 2 %.Conclusion: The method is fast, accurate, precise and sensitive, and hence it can be employed for routine quality control of tablets containing both drugs in quality control (QC) laboratories and pharmaceutical industry.Keywords: Phenylephrine, Ibuprofen, Simultaneous determination, Validation, Gradient HPLC.
Highlights
Phenylephrine (PHE) is chemically named as (R)-3-[-1-hydroxy-2-(methylamino) ethyl] phenol (Figure 1A)
Its effects are due to the inhibitory actions on cyclo-oxygenases, which are involved in the synthesis of prostaglandins
To ensure that the resolution and reproducibility of the high performance liquid chromatography (HPLC) system was adequate for the analysis, a system suitability test was established
Summary
Phenylephrine (PHE) is chemically named as (R)-3-[-1-hydroxy-2-(methylamino) ethyl] phenol (Figure 1A). It is a nasal decongestant which helps to relieve a blocked nose. It reduces the size of the blood vessels in the nose and sinuses enabling one to breathe more . It is used as paroxysmal supraventricular tachycardia, mydriasis, and haemorrhoids [1]. Ibuprofen (IBU) is chemically named as (RS)-2(4-(2-methylpropyl) phenyl) propanoic acid (Figure 1B). It is used to relieve symptoms of a wide range of illnesses such as headaches, backache, pains, migraine, cold and flu symptoms and arthritis. Its effects are due to the inhibitory actions on cyclo-oxygenases, which are involved in the synthesis of prostaglandins
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