Simultaneous Spectrophotometric Determination of Benzyl Alcohol and Diclofenac in Pharmaceutical Formulations by Chemometrics Method

摘要

Diclofenac sodium (DS) is a drug with analgesic,antipyretic,and anti-inflammatory properties.It is present in numerous pharmaceutical preparations.In injectable forms,it is usually accompanied by benzyl alcohol (BA) as an excipient,which is used as a blocking anesthetic (4%) and an antiseptic (4-10%).In this work a spectrophotometric methodology was applied in order to determine benzyl alcohol and diclofenac in injectable formulations by applying a multivariate calibration method.By a multivariate calibration method such as partial least squares (PLS),it is possible to obtain a model adjusted to the concentration values of the mixtures used in the calibration range.In this study,the concentration model is based on absorption spectra in the 230-320 nm range for 25 different mixtures of benzyl alcohol and diclofenac.Calibration matrix contains 10-95 and 1-50 mug mL~(-1) for benzyl alcohol and diclofenac,respectively.The root mean square errors of prediction (RMSEP) for benzyl alcohol and diclofenac were 3.0776 and 1.7557,respectively.The proposed method was validated by using a set of synthetic sample mixtures and subsequently applied to simultaneous determination of benzyl alcohol and diclofenac in two different pharmaceutical formulations.