Abstract

DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR ESTIMATION OF ILAPRAZOLE IN BULK AND TABLET DOSAGE FORMS

Prashanta Basnet*

Abstract

This paper describes a validated high-performance liquid chromatographic (HPLC) method for estimation of Ilaprazole in tablet dosage form. The HPLC separation was achieved on a stainless steel column 15cm x 4.6 mm, packed with octylsilane bonded to porous silica (5μm) using a mobile phase of 60 volumes of buffer, 40 volumes of acetonitrile in the ratio of 60:40 and pH adjusted to 5.5 with dilute orthophosphoric acid, with a flow rate of 1.0 ml per minute, with an injection volume of 10μl and elution measured at 305nm spectrophotometer. The calibration curve showed good linear relationship with r2 = 0.9953 for Ilaprazole standard. The method was validated in terms of linearity, accuracy, precision (repeatability), precision (intermediate), specificity, solution stability, and robustness based on ICH guidelines (Q2 R1). The method was successfully applied for routine analysis of Ilaprazole in Pharmaceutical Tablet dosage forms.

Keywords: Ilaprazole, Tablet Dosage form, HPLC, validation, ICH guidelines.