Application of different spectrophotometric methods for simultaneous determination of elbasvir and grazoprevir in pharmaceutical preparation.
15 Jan 2018-Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy (Elsevier)-Vol. 189, pp 154-160
TL;DR: The first three UV spectrophotometric methods have been developed of simultaneous determination of two new FDA approved drugs namely; elbasvir and grazoprevir in their combined pharmaceutical dosage form and there was no significant difference between the proposed methods and the manufacturing one with respect to the validation parameters.
About: This article is published in Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy.The article was published on 2018-01-15. It has received 29 citations till now. The article focuses on the topics: Elbasvir & Grazoprevir.
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1,148 citations
TL;DR: In this paper, three analytical methods have been developed and applied for determination of velapatasvir and sofosbuvir in their new FDA-approved pharmaceutical dosage form.
Abstract: Three analytical methods have been developed and applied for determination of velapatasvir and sofosbuvir in their new FDA-approved pharmaceutical dosage form. Capillary electrophoresis has been in...
17 citations
Cites methods from "Application of different spectropho..."
...separation.([2,3]) Savitsky–Golay filters (SGF) is a signal processing method for resolving any UV overlapping spectra between different compounds presented in the same mixture....
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TL;DR: A high-performance liquid chromatographic method has been developed for simultaneous determination of elbasvir and grazoprevir; two new Food and Drug Administration (FDA) approved drugs and has been successfully applied for simultaneously determination of the studied drugs in their pharmaceutical dosage form.
Abstract: A high-performance liquid chromatographic method has been developed for simultaneous determination of elbasvir and grazoprevir; two new Food and Drug Administration (FDA) approved drugs. The two drugs were co-formulated for treatment of hepatitis C virus in their combined pharmaceutical dosage form. The chromatographic separation has been achieved using a reversed phase BDS Hypersil C18 column with a mobile phase consists of acetonitrile:methanol (50:50, v/v) at flow rate of 1 mL/min and UV detection at 253 nm. Computational investigation for finding the best stationary phase revealed that C18 column fits better for the simultaneous chromatographic analysis of the studied drugs. Linearity, accuracy and precision have been found to be acceptable over the concentration range of 1-20 μg/mL for the studied drugs. The described method has been successfully applied for simultaneous determination of the studied drugs in their pharmaceutical dosage form.
16 citations
TL;DR: In this paper, a highly sensitive, selective and accurate second derivative synchronous fluorescence spectroscopic method was developed for the simultaneous determination of elbasvir and grazoprevir in their pharmaceutical dosage form without previous separation.
Abstract: Elbasvir and grazoprevir combination has been newly approved for the treatment of patients infected with hepatitis C virus. In the present work, a highly sensitive, selective and accurate second derivative synchronous fluorescence spectroscopic method was developed for the simultaneous determination of elbasvir and grazoprevir in their pharmaceutical dosage form without previous separation. The developed method based on the measurement of the synchronous fluorescence intensity of the studied drugs at constant wavelength difference (Δλ) = 50 nm and the peak amplitudes of the second derivative were measured at 308 and 389 nm for the quantitative analysis of elbasvir and grazoprevir, respectively. Different parameters that affect the synchronous fluorescence intensity of the cited drugs were carefully studied and optimized. Calibration graphs were found to be linear over the concentration range of 100–800 ng mL−1 for elbasvir and 150–900 ng mL−1 for grazoprevir. The developed method was successfully applied to the quantitative analysis of the two drugs in Zepatier® tablets and spiked human plasma. The results were statistically compared with another published analytical method with no significant difference by applying a Student t-test and variance ratio F-test.
14 citations
TL;DR: A sensitive, selective and accurate synchronous fluorescence spectroscopic method was utilized for simultaneous estimation of elbasvir and grazoprevir in their pharmaceutical formulation and was successfully applied to the quantitative analysis of the two drugs in Zepatier® tablets.
13 citations
References
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TL;DR: Partial least squares (PLS) as discussed by the authors is one of the most popular spectral analysis methods for spectral analysis, which is composed of a series of simpllfled classical least-squares (CLS) and ILS steps.
Abstract: Partial leastgquares (PLS) methods for spectral analyses are related to other multlvarlate callbratlon methods such as classical least-squares (CLS), Inverse least-squares (ILS), and prlnclpal component regression (PCR) methods which have been used often In quantitative spectral analyses. The PLS method which analyzes one chemlcal component at a tbne Is presented, and the basis for each step In the algorithm Is explained. PLS callbratlon Is shown to be composed of a series of simpllfled CLS and ILS steps. This detalled understandlng of the PLS algorithm has helped to ldentlfy how chemically Interpretable qualltatlve spectral lnformatlon can be obtained from the lntennedlate steps of the PLS algorithm. These methods for extractlng qualitative Information are demonstrated by use of simulated spectral data. The qualltatlve Information directly available from the PLS analysis Is superlor to that obtained from PCR but is not as complete as that which can be generated during CLS analyses. Methods are presented for selecting optbnal numbers of loading vectors for both the PLS and PCR models In order to optimize the model while simultaneously reduclng the potential for overfittlng the caHbratlon data. Outlier detection and methods to evaluate the statlstlcal slgnlflcance of resuits obtalned from the dMerent cahatlon methods applied to the same spectral data are also discussed.
2,443 citations
TL;DR: A review of available methods for variable selection within one of the many modeling approaches for high-throughput data, Partial Least Squares Regression, to get an understanding of the characteristics of the methods and to get a basis for selecting an appropriate method for own use.
1,180 citations
"Application of different spectropho..." refers background in this paper
...Wavelengths selection was done, in such a way that uninformative variables were eliminated and the variables selection was achieved [20]....
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1,148 citations
29 Sep 2017
530 citations
"Application of different spectropho..." refers methods in this paper
...The proposed method was validated according to ICH guidelines [15]....
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TL;DR: After suitable modifications, genetic algorithms can be a useful tool in the problem of wavelength selection in the case of a multivariate calibration performed by PLS because the variables selected by the algorithm often correspond to well‐defined and characteristic spectral regions instead of being single variables scattered throughout the spectrum.
Abstract: After suitable modifications, genetic algorithms can be a useful tool in the problem of wavelength selection in the case of a multivariate calibration performed by PLS. Unlike what happens with the majority of feature selection methods applied to spectral data, the variables selected by the algorithm often correspond to well-defined and characteristic spectral regions instead of being single variables scattered throughout the spectrum. This leads to a model having a better predictive ability than the full-spectrum model; furthermore, the analysis of the selected regions can be a valuable help in understanding which are the relevant parts of the spectra. After the presentation of the algorithm, several real cases are shown. Copyright © 2000 John Wiley & Sons, Ltd.
516 citations
"Application of different spectropho..." refers methods in this paper
...The GA was run on 171 variables for EBV and GRV using a PLS with the maximum number of latent variables determined by cross-validation on the model containing all the variables [21]....
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