Validation of UV Spectrophotometric Method for Quantitative Determination of Entacapone in Tablets Using Experimental Design of Plackett‐Burman for Robustness Evaluation and Comparison with HPLC

Abstract

Validation of UV spectrophotometric method for quantitative determination of entacapone in tablets using acetonitrile as solvent. The validation of analytic method was realized through the study of the following analytic parameters: specify linearity, precision, accuracy, and robustness. The excipients of the formulation did not interfere at 305 nm, demonstrating the specificity of the method. The method was linear (r=0.99996) at concentrations ranging from 3.0 to 20.0 µg ml−1, precise (repeatability and intermediated precision), exact (method of standard addition), and robust. The results confirmed that the method is valid and useful to the routine quality control of entacapone in coated tablets. The method was compared to a high‐performance liquid chromatography (HPLC) method, which was previously developed and validated to the same drug. There was not a significant difference between the methods for entacapone quantitation.