Abstract

EFFECT OF PH AND ROLE OF IONIZATION ON CHROMATOGRAPHIC PERFORMANCE OF NATEGLINIDE

Manisha S. Phoujdar*, Pankaj R. Deore, Shwetal P. Vassa

ABSTRACT

A simple, accurate, precise, robust and economical method has been developed and validated as per ICH guidelines. Isocratic elution was employed at the flow rate of 1 mL/min using mobile phase methanol: phosphate buffer (75:25 v/v, pH 2.6) on “Enables” C-18 (250 mm × 4.6 mm, 5 μm) column, detection point was set on λmax210 nm. The detector response was found to be linear in the range of concentrations 50 – 110 μg/mL.The interference of ionized and unionized species on chromatographic performance was investigated and was found to be in pH range 2.9 – 6.2. Various pH conditions were employed using suitable buffers to study the effect of pH and role of ionization on chromatographic performance of nateglinide.

Keywords: Ionization, Method development, Nateglinide, pH, RPHPLC, Validation.