| Summary: | Generaly, analysis of two or more active substances is carried out using
chromatographic tehniques, which need a long time and high costs, making it less
suitable to be used in routine testing in quality control of drug. Due to the
increasing number of multicomponent drug products, it is necessary to develop a
quick, simple, safe and low cost analytical method. By the development of
computer software and multivariate analysis, the uv-vis spectrophotometric
method is widely used for the analysis of multicomponent compounds
simultaneously. The aim of this study is to develop uv-vis spectrophotometry
coupled with multivariate calibration of partial least square (PLS) for quantitative
analysis of methampyron (MET), thiamin (Vit B1) and pyridoxin (vit B6) in the
presence of cyanocobalamine without separation step.
The study of uv-vis spectrophotometry in combination with multivariate
calibration is conducted in three phases, namely the calibration, validation and
samples assay. The evaluation of calibration model was based on the coefficient
of determination (R2), root mean square error of calibration (RMSEC), root mean
square error of cross validation (RMSECV), root mean square error of prediction
(RMSEP) and the predicted residual sum of square (PRESS). The HPLC methods
used for comparison method.
The results showed that uv spectrophotometry combined with PLS
multivariate calibration can be used for quantitative analysis of drugs. The
coefficient of determination (R2) for the relationship between actual values and
predicted values for all studied drugs was higher than 0,99 indicating good
accuracy. The RMSEC, RMSECV, RMSEP and PRESS values obtained were
relatively low indicating good precision. The level of MET, Vit B1 and Vit B6
obtained using UV spectrophotometry combination with PLS are 96.27 ± 0.38 %,
100.48 ± 1.82 % and 98.45 ± 1.66 % respectively, and those by HPLC are 96.06 ±
0.76 %, 99.35 ± 1.56 % and 98.96 ± 0.67 %, for MET, Vit B1 and Vit B6
respectively. The accuracy and presision results of developed method showed no
significant difference compared to those obtained by HPLC. The developed
method was succesfully used for analysis of methampyron, thiamin and pyridoxin
in tablet dosage form.
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