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

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.

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2024-11-29
2025-01-22

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/content/journals/cpa/10.2174/0115734129346572241125111122
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Design Expert-Supported Method Development and Validation of Cilostazol in Pharmaceutical Formulation Using High-Performance Liquid Chromatography
Bentham Science Publishers ; https://doi.org/10.2174/0115734129346572241125111122
/content/journals/cpa/10.2174/0115734129346572241125111122
/content/journals/cpa/10.2174/0115734129346572241125111122
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  • Article Type:     Research Article
Keywords: Box Behnken design ; Design Expert 11 ; Cilostazol ; ICH Q2A guidelines ; Response surface methods (RSM) ; Quality by Design (QBD)

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