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Asian Journal of Pharmaceutical Analysis
Year : 2025, Volume : 15, Issue : 1
First page : ( 25) Last page : ( 30)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.52711/2231-5675.2025.00005

Development and validation of a stability indicating HPLC method for the simultaneous determination of flunarizine and domperidone in tablet dosage form

Dangariya Akshay V.*, Patel Nilesh K.

B.K. Mody Government Pharmacy College, Rajkot, Gujarat

*Corresponding Author E-mail: akshaydangariya1308@gmail.com

Online published on 23 May, 2025.

Abstract

This present work aimed to develop a simple, accurate, precise, and reproducible Stability Indicating RP-HPLC method for the simultaneous determination of Flunarizine and Domperidone Separation was achieved by chromatographic condition ACE Excel C18(250mm x 4.6mm, 5μm) column with the mobile phase composition 10 mM Potassium Dihydrogen Phosphate buffer: Acetonitrile: Methanol (40:30:30% v/v). The injection volume was set to 10μL. The detection was carried out at 220nm with a 1.0mL/min flow rate. Flunarizine and Domperidone were eluted with retention times of 3.4 min and 9.7 min respectively. Linearity was obtained over the concentration range of 25-75μg/mL for Flunarizine and 50-150μg/mL for Domperidone drug with for both correlation coefficients was 0.999. Accuracy was obtained between 98.89-101.84% and 98.46-101.55% for Flunarizine and Domperidone respectively. LOD was found to be 0.22μg/mL and 0.42μg/mL and LOQ were found to be 0.68μg/mL and 1.29μg/mL for Flunarizine and Domperidone respectively. The result revealed that the developed method is suitable for routine analysis of determining Flunarizine and Domperidone in a tablet dosage form.

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Keywords

Force Degradation, RP-HPLC, ICH Guideline Q2(R1), Flunarizine, Domperidone.

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