Abstract

DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR ESTIMATION OF ILAPRAZOLE IN AN INHOUSE MULTIPLE EMULSION FORMULATION

Miss. Tejaswini V. Tidke, Dr. Anil P. Dewani, Dr. A. V. Chandewar, Dr. Archana Kajale and Miss. Komal Madavi

ABSTRACT

Aim and Objective: The aim of this work is to Develop and Validate a HPLC method for estimation of ilaprazole in bulk in an inhouse Multiple emulsion formulation. The objective of this work was to developed Analytical method should be simple, rapid and economical. To validate developed HPLC method for Ilaprazole in multiple Emulsion. To obtain consistent, reliable, and accurate data from the experimentation. To validate an analytical method as per ICH guidelines. Preparation of Multiple Emulsion. Apply the developed HPLC method on formulated multiple emulsion. The elution was achieved by using a Kinetex C8 (250 cm x 4.6 mm, 5micron) maintained at room temperature, in isocratic mode of analysis, columnwas equilibrated by mobile phase phosphate Buffer: Acetonitrile (60:40v/v). The flow rate was set to 1.0 mL/min and PDA detection done at wavelength of 276 nm. The retention time of IPR was found to be 3.194 min. The system suitability results were found within acceptance criteria for developed method. The validation was carried out in which linearity was carried out in range of 50 % to 150 %, where R2 was found for IPR was found to be 0.9998 respectively. The percentage recovery for IPR was found to be 98.75% and 99.83%.

Keywords: IPR, MP, HPLC, Linearity, Precision, Accuracy.