Current Pharmaceutical Analysis

Author(s): Calamur Nagarajan Nalini, Afnaan Afreen and Bhagyalata Satapathy*

DOI: 10.2174/0115734129346572241125111122

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Design Expert-Supported Method Development and Validation of Cilostazol in Pharmaceutical Formulation Using High-Performance Liquid Chromatography

Page: [1033 - 1042] Pages: 10

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Abstract

Background: Developing a simple HPLC method requires an expansive array of literary evidence and experimental routines to perceive the nature of a drug and eventually determine the specific mobile phase and column to be used for attaining better results.

Objective: The study aimed to develop and optimize a new, simplified, robust, and sensitive method for the determination of cilostazol in tablets by high-performance liquid chromatography using a Box Behnken design.

Methods: The chromatographic separation was carried out on an ODS C18 (4.6 X 250mm and 5μm) column with acetonitrile and methanol (25:75 % v/v) at an effluent flow rate of 1 mL/min and detected at 257 nm.

Result: The method was found to be linear in the concentration range of 10-50 μg/mL, and the correlation coefficient was found to be 0.988, and the recovery of cilostazol was 98.16%. The optimized method validated as per ICH Q2A guidelines was found to be accurate, precise, robust, and stable.

Conclusion: This research thus throws light on the implementation of statistical multivariate analysis techniques used for drug analysis.

Keywords: Quality by Design (QBD), Response surface methods (RSM), Box Behnken design, Design Expert 11, Cilostazol, ICH Q2A guidelines.