Abstract
A simple and robust high-performance liquid chromatography method with UV detection was developed to quantify acetic acid in potassium clavulanate. The chromatographic separation was performed on the Hypersil BDS C18 column (250×4.6 mm, 5 μm) with optimized response surface methodology combined Box–Behnken experimental design. The mobile phase comprises of a buffer prepared by ammonium dihydrogen orthophosphate (20 mM) containing 0.01% triethylamine, maintained pH between 2.8–3.2 using phosphoric acid and % acetonitrile as per Box–Behnken factorial design. The detection was performed at 235 nm with a mobile phase flow rate of 1 ml/min. The method was validated as per the ICH guidelines. The linearity of the proposed method was rectilinear within the range of 2.5–24.8 μg/ml. The value of the limit of detection (LOD) & limit of quantitation (LOQ) by the validated method was found to be 1.9 and 5.8 μg/ml, respectively. The robustness and ruggedness studies were conducted by small changes with parameters in the proposed method. The % RSD values were within the accepted limit of criteria. This developed method can quantify routine acetic acid content analysis in potassium clavulanate pharmaceutical formulations.
Recommended Citation
Haque, SK Manirul
(2022),
Optimized and Validated Box–Behnken Design Combined Response Surface Methodology to Quantify Acetic Acid Content in Potassium Clavulanate Using High–Performance Liquid Chromatography,
Yanbu Journal of Engineering and Science: Vol. 19:
Iss.
2, 50-61.
DOI: https://doi.org/10.53370/001c.37877
Available at:
https://yjes.researchcommons.org/yjes/vol19/iss2/4
