Gradient High Performance
Liquid Chromatography Method Development and Validation
for Simultaneous Determination of Phenylephrine and
Ibuprofen in Tablet Dosage Form
Venkata Raveendra Babu
Vemula1* and Pankaj Kumar Sharma2
1Faculty of Pharmacy, Pacific
Academy of Higher Education and Research University,
Udaipur-313024, 2School of Pharmaceutical
Sciences, Jaipur National University, Jaipur-302025,
Rajasthan, India
*For correspondence:
Email:
raveendra.vemula@gmail.com;
Tel: 91+9705126244
Received: 16 June 2013
Revised accepted: 17 March 2014
Tropical Journal of Pharmaceutical Research, June
2014; 13(6): 967-974
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.
