Univariate calibrations with or without chemometric assistance for determination of drugs lacking peak maxima in their zero-order profiles
Ragaa Magdy; A. Hemdan; Nermine Victor Fares; Maha Farouk;
Abstract
Trandolapril has no sharp peak in its zero-order spectrum and therefore, it is difficult to be measured by direct
spectrophotometry. In this manuscript, several univariate and multivariate spectrophotometric methods were
developed and validated for determination of Trandolapril (TR) and Verapamil (VR) combination. The first
method for measuring Trandolapril is Constant Multiplication-Spectrum Subtraction (CM-SS), where
Trandolapril was measured at 210 nm in its zero-order curve after elimination of Verapamil spectrum. Second
and third methods are two Base Points (2BP) and area under the curve (AUC) to measure Trandolapril concen-
tration without depending on the shoulder peak. The fourth method for Trandolapril is Derivative Subtraction
(DS) that utilizes the sharp peak appeared in the first order spectrum of Trandolapril. Verapamil was determined
by two methods, Constant Multiplication (CM) and Derivative Subtraction-Constant Multiplication (DS-CM).
Also, two multivariate methods were developed for measurement of the mixture, Partial Least Squares (PLS)
and Principal Component Regression (PCR). All the developed methods were validated as per ICH guidelines
and the results proved that the developed methods are accurate and selective. Moreover, a statistical comparison
between the developed methods and a reference method was done. Also, One-way ANOVA statistical test was
done between all the proposed univariate and multivariate spectrophotometric methods.
spectrophotometry. In this manuscript, several univariate and multivariate spectrophotometric methods were
developed and validated for determination of Trandolapril (TR) and Verapamil (VR) combination. The first
method for measuring Trandolapril is Constant Multiplication-Spectrum Subtraction (CM-SS), where
Trandolapril was measured at 210 nm in its zero-order curve after elimination of Verapamil spectrum. Second
and third methods are two Base Points (2BP) and area under the curve (AUC) to measure Trandolapril concen-
tration without depending on the shoulder peak. The fourth method for Trandolapril is Derivative Subtraction
(DS) that utilizes the sharp peak appeared in the first order spectrum of Trandolapril. Verapamil was determined
by two methods, Constant Multiplication (CM) and Derivative Subtraction-Constant Multiplication (DS-CM).
Also, two multivariate methods were developed for measurement of the mixture, Partial Least Squares (PLS)
and Principal Component Regression (PCR). All the developed methods were validated as per ICH guidelines
and the results proved that the developed methods are accurate and selective. Moreover, a statistical comparison
between the developed methods and a reference method was done. Also, One-way ANOVA statistical test was
done between all the proposed univariate and multivariate spectrophotometric methods.
Other data
Title | Univariate calibrations with or without chemometric assistance for determination of drugs lacking peak maxima in their zero-order profiles | Authors | Ragaa Magdy; A. Hemdan; Nermine Victor Fares ; Maha Farouk | Issue Date | 6-Aug-2018 | Publisher | Elsevier | Journal | Spectrochimica Acta - Part A: Molecular and Biomolecular Spectroscopy | Issue | 206 | Start page | 207 | End page | 215 | DOI | 10.1016/j.saa.2018.08.007 |
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