Abstract

EFFECT OF pH ON RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF IBUPROFEN IN BULK AND TABLET DOSAGE FORM

Manisha S. Phoujdar*, Ritesh T. Kucheriya and Shwetal P. Vassa

ABSTRACT

A simple, accurate, precise and robust high performance liquid chromatography method has been developed and validated for analysis of Ibuprofen as per ICH guidelines. The chromatographic separation was achieved isocratically on a “Enables” C-18 (250 mm ×4.6 mm, 5 μm) column containing a mobile phase of acetonitrile: phosphate buffer: water (80:10:10 v/v, pH 2.6), at the flow rate of 1 mL/min. UV detection was performed at 218 nm. The detector response was found to be linear in the range of concentrations 40–100 μg/mL. The interference of ionized and unionized compounds on chromatographic performance was investigated in pH range of 2.6–6.4.

Keywords: Ibuprofen, Method development, Effect of pH, Validation, ICH guideline.