ISSN 2995-9246
International Journal of Chemistry | Vol. 1, No. 10, October 2010 | pp. 78–86
DOI: 10.46882/2010/IJC/000010
Article Type: Original Research Paper
Title: Development and Validation of a RP-HPLC Method for the Simultaneous Quantification of Paracetamol and Ibuprofen in Pharmaceutical Formulations
Names of Authors: Chinyere N. Nwosu¹, Alistair K. Brown²
Authors’ Affiliations:
¹Department of Pharmaceutical Chemistry, University of Port Harcourt, Choba, Nigeria
²School of Chemistry, University of Edinburgh, Edinburgh, United Kingdom
Abstract: A simple, rapid, precise, and accurate reversed-phase high-performance liquid chromatography (RP-HPLC) method was engineered and validated for the concurrent analysis of paracetamol and ibuprofen in tablet dosage forms. The chromatographic separation was accomplished on a C18 stationary phase column (250 mm x 4.6 mm, 5 micro-m particle size). The optimized mobile phase consisted of a mixture of water adjusted to pH 3.2 using orthophosphoric acid and acetonitrile in an isocratic ratio of 40:60 (v/v). The flow rate was regulated at 1.0 mL/min, and the analytes were supervised via UV detection at a wavelength of 230 nm. The retention times for paracetamol and ibuprofen were found to be 2.45 minutes and 5.12 minutes, respectively, indicating rapid baseline separation. The method was validated according to International Council for Harmonisation (ICH) guidelines for parameters including linearity, accuracy, precision, specificity, limit of detection (LOD), and limit of quantification (LOQ). Linearity was established over a concentration domain of 5.0–50.0 micro-g/mL for paracetamol and 10.0–100.0 micro-g/mL for ibuprofen, generating correlation coefficients (R²) exceeding 0.999. The recovery percentages fell within 98.5%–101.2%, proving excellent accuracy. The low relative standard deviation (%RSD < 2.0%) obtained for intra-day and inter-day evaluations confirmed the robustness of the methodology for routine quality control assay analysis.
Keywords: RP-HPLC, Isocratic separation, Validation, Paracetamol, Ibuprofen, Pharmaceutical formulation, ICH guidelines
Manuscript Timeline: Received: July 11, 2010; Revised: August 25, 2010; Accepted: September 14, 2010; Published: October 05, 2010.