Detection of Lipitor® counterfeits: A comparison of NIR and Raman spectroscopy in combination with chemometrics

Peinder, Peter de; Vredenbregt, M.J.; Visser, Taco D.; Kaste, D. de

doi:10.1016/j.jpba.2008.02.016

Cited by 78 publications

(54 citation statements)

References 17 publications

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“…The PCR model could address most of these factors, because each sample can be irradiated rapidly and examined directly with the use of an optical probe, without prior preparation, to obtain a single spectrum, which minimizes human error. Furthermore, the use of Raman spectroscopy as an analytical technique offers the possibility of measurements in real time at-line, avoiding the storage time required until the medicine's stock release, preventing possible rejections/disposal by furnishing actual concentration values, and even measuring the concentration through containers by standard Raman and offset spatially Raman spectroscopy [54][55][56].…”

Section: Discussionmentioning

confidence: 99%

Multivariate Method Based on Raman Spectroscopy for Quantification of Dipyrone in Oral Solutions

Guimarães

Moreira

Lourenço

et al. 2018

Journal of Spectroscopy

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This work employed a quantitative model based on Raman spectroscopy and principal component regression (RS/PCR) to quantify the active ingredient dipyrone (metamizole) in commercially available formulations as an analytical methodology for quality control in the pharmaceutical industry. Raman spectra were collected using a dispersive Raman spectrometer (830 nm, 250 mW excitation, and 20 s exposure time) coupled to a Raman probe. Solutions of dipyrone diluted in water in the range of 80 to 120% of the concentration of commercial formulations (500 mg/mL) were used to develop a calibration model based on PCR to obtain the figures of merit for class I validation from the Brazilian Sanitary Surveillance Agency (ANVISA, RE no. 899/2003). This spectral model was then used to predict the concentration of dipyrone in commercial formulations from distinct brands with 500 mg/mL. A prediction error of 6.5 mg/mL (1.3%) was found for this PCR model using the diluted samples. Commercial formulations had predicted concentrations with a difference below 5.0% compared to the label concentration, indicating the applicability of Raman spectroscopy for quality control in the final product.

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Section: Discussionmentioning

confidence: 99%

Multivariate Method Based on Raman Spectroscopy for Quantification of Dipyrone in Oral Solutions

Guimarães

Moreira

Lourenço

et al. 2018

Journal of Spectroscopy

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“…17,20 PLS-DA is also based on the PCA decomposition, the difference being that the combinations of variables, called PLS factors or latent variables, are defined in such a way that the covariance of the instrumental data with the response variable (predefined classes) are maximized, leading to quantitative methods with low errors and high discrimination power between the different classes in discriminant analysis. 13,15,18,20 PLS-DA is performed using binary coding, in which a dummy discrete response vector y is attributed to the data set, such as 0 for counterfeit samples and 1 for original samples. 14,17,21,22 In the training stage, the method is trained to assign "membership values", one for each class; a test sample is then assigned to a specific class if its y value surpasses a specific prediction threshold that may be estimated by establishing confidence limits for each sample classified.…”

Section: Partial Least Squares -Discriminant Analysis (Pls-da)mentioning

confidence: 99%

“…[8][9][10][11][12] Spectroscopic techniques such as Raman, near infrared, and Fourier transform infrared (FTIR), together with chemometric tools, are being successfully used to analyze suspected counterfeit medicines. [13][14][15][16][17][18][19] They have the advantage of being less time-consuming than chromatographic methods, with little or no sample preparation. [13][14][15]19 However, to the best of our knowledge, only one work using spectroscopic methods to analyze anabolic steroid medicines has been published so far, describing the investigation of the composition of methandrostenolone-containing tablets by near infrared and Raman spectroscopy.…”

Section: Introductionmentioning

confidence: 99%

Detection of Counterfeit Durateston® Using Fourier Transform Infrared Spectroscopy and Partial Least Squares - Discriminant Analysis

Neves¹,

Talhavini²,

Braga³

et al. 2016

J. Braz. Chem. Soc.

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Medicines containing anabolic steroids are one of the main targets for counterfeiting worldwide, including Brazil. The aim of this work was to propose a method for discriminating original and counterfeit Durateston ® ampoules by Fourier transform infrared spectroscopy (FTIR) followed by chemometric analysis. Ninety-six ampoules of Durateston ® , 49 originals and 47 counterfeits, were analyzed by gas chromatography with mass spectrometry (GC-MS) and by FTIR. Principal component analysis was applied to the infrared spectra to detected different clusters, corresponding to original samples and different types of counterfeits. A partial least squares -discriminant analysis method was proposed to discriminate original samples from those counterfeits that were indistinguishable from the originals in the infrared analysis. A training subset comprised of onethird of the available spectra was used to establish a suitable model that correctly discriminated all samples in the test subset, resulting in 0% of false positive or negative results and 100% of efficiency rate, sensitivity and specificity. In addition to the low cost of the infrared technique, the proposed method is fast, reliable and suitable to replace GC-MS methods used in Durateston ® ampoule analyses to detect counterfeiting.

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“…These units give investigators the flexibility of making realtime measurements to screen drug products and are particularly useful when coupled with multivariate methods. Methods, such as principal component analysis (PCA) and soft independent modelling of class analogies (SIMCA), are commonly used to detect counterfeit products [7]. Despite the studies [8] detailing successful implementation of portable Raman instruments to screen tablet-form drug products, the number of studies including capsule-form products is conspicuously lagging.…”

Section: Introductionmentioning

confidence: 99%

Field-Deployable Raman Anti-Counterfeit Screening of Tamiflu Capsules

Loethen¹,

Rodriguez²

2015

AJAC

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In an effort to promote the availability of safe and effective drugs, the US Food and Drug Administration is developing spectroscopic methods to assess the quality of drugs in the field. Here we report a rapid screening classification method for Tamiflu (oseltamivir phosphate) capsules using a portable Raman spectrometer to perform screening on three solid oral dosage strengths of Tamiflu, 30 mg, 45 mg and 75 mg. Tamiflu is an antiviral drug that is stockpiled for use in the event of pandemic influenza outbreak. The qualitative classification methods reported were developed using the Raman spectra of intact capsules. The classification algorithms used were able to reliably distinguish the three dosage strengths of Tamiflu. These qualitative models are validated with additional Tamiflu samples from different batches and simulated counterfeits of Tamiflu. The probability that a test sample belongs to each dosage strength class is calculated, and strict class predictions are used to assign each sample to a particular class. The classification methods reported here enable development of user-independent, field-deployable methods for finished drug products and are able to correctly assign 92% of the validation samples using authentic Tamiflu and 100% of the simulated counterfeits.

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Detection of Lipitor® counterfeits: A comparison of NIR and Raman spectroscopy in combination with chemometrics

Cited by 78 publications

References 17 publications

Multivariate Method Based on Raman Spectroscopy for Quantification of Dipyrone in Oral Solutions

Multivariate Method Based on Raman Spectroscopy for Quantification of Dipyrone in Oral Solutions

Detection of Counterfeit Durateston® Using Fourier Transform Infrared Spectroscopy and Partial Least Squares - Discriminant Analysis

Field-Deployable Raman Anti-Counterfeit Screening of Tamiflu Capsules

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