Impurity profiling of pharmaceuticals by thin-layer chromatography

Ferenczi-Fodor, K.; Végh, Zoltán; Renger, Bernd

doi:10.1016/j.chroma.2010.12.044

Cited by 29 publications

(17 citation statements)

References 40 publications

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“…Depending on the applications of the methods described in this paper, they should be fully validated for parameters such as accuracy, precision (repeatability and intermediate precision), specificity, linearity, range and robustness under relevant guidelines such as those described by the International Conference on Harmonization [20] or subjected to an interlaboratory study [21] to prove that they are suitable for their intended purpose by users.…”

Section: Discussionmentioning

confidence: 99%

Development of Quantitative HPTLC-Densitometry Methods Following a Model Approach for Transfer of TLC Screening Methods for Pharmaceutical Products of Metformin HCL, Potassium Clavulanate, Caffeine, Fluoxetine HCL, and Gabapentin

Nguyen¹,

Zhang²,

Sherma³

2017

Studia UBB Chemia

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ABSTRACT. Transfer of thin-layer chromatography Global Pharma HealthFund Minilab kit protocols for detecting counterfeit drugs in pharmaceutical products in the field to quantitative high-performance TLC (HPTLC)-densitometry methods was carried out for potassium clavulanate and metformin HCl using a model process published earlier. HPTLC-densitometry methods were also developed following the model process for caffeine, fluoxetine HCl, and gabapentin, for which methods are not included in the Minilab manual. The model process involves use of EMD Millipore Premium Purity silica gel 60 F254 plates, automated sample and standard solution application with a CAMAG Linomat 4, and automated densitometry with a CAMAG Scanner 3 for determination of peak purity and identification and for quantification. Detection methods for counterfeit samples of the three drugs not covered in the Minilab manual were also developed and posted online with open access as supplemental methods for the Compendium of Unofficial Methods for Rapid Screening of Pharmaceuticals by Thin Layer Chromatography.

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Section: Discussionmentioning

confidence: 99%

Development of Quantitative HPTLC-Densitometry Methods Following a Model Approach for Transfer of TLC Screening Methods for Pharmaceutical Products of Metformin HCL, Potassium Clavulanate, Caffeine, Fluoxetine HCL, and Gabapentin

Nguyen¹,

Zhang²,

Sherma³

2017

Studia UBB Chemia

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“…It has been shown that, with some additional training, some operators in these countries can competently perform HPTLC-densitometry [5,14] and obtain much more information and better results compared to visual semiquantitative TLC methods. If necessary, full validation of the developed HPTLC-densitometry quantitative methods can be performed according to International Conference on Harmonization (ICH) guidelines for HPTLC pharmaceutical analysis [15,16], including accuracy, precision (repeatability and intermediate precision), specificity, linearity, range, and robustness.…”

Section: Discussionmentioning

confidence: 99%

A model procedure for the transfer of TLC pharmaceutical product screening methods designed for use in developing countries to quantitative HPTLC-densitometry methods

O'Sullivan¹,

Sherma²

2012

Acta Chromatographica

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Summary.Transfer of four rapid thin-layer chromatography (TLC) screening methods used to detect substandard and counterfeit pharmaceutical products to quantitative high-performance TLC (HPTLC)-densitometry methods is demonstrated. These methods for acetaminophen, acetylsalicylic acid, ibuprofen, and chlorpheniramine maleate are contained in a Compendium of methods developed by Kenyon and Layloff for use in countries with limited resources. The new quantitative methods use Merck HPTLC silica gel 60 F 254 glass plates, automated standard and sample application, and automated densitometry for detection, identification, and quantification. Standard and sample solution preparation and application procedures for obtaining calibration curves and bracketed samples are described. The HPTLC plates give better efficiency, selectivity, and resolution than TLC, and the new methods overcome the deficiencies in technology related to manual application and visual zone comparison that do not allow the Compendium TLC procedures to support regulatory compliance actions. These transferred methods can be fully validated according to International Conference on Harmonization (ICH) guidelines or by interlaboratory studies if their applications require. The approach described can be used to transfer the remaining Compendium methods as well as the GPHF [Global (formerly German) Pharma Health Fund E.V.] Minilab kit TLC screening methods.

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“…9 This method is often used for checking the purity and homogeneity of drugs in pharmaceutical analysis (impurity profiling). 10 Moreover, a few chemistry experiments were published, which used IR spectroscopy as educational part of the laboratory. 11,12 However, there are not many laboratories that extended learning of students from synthesis, spectroscopic and chromatography methods to molecular modeling The proposed laboratory consists of three main sections (synthesis, analysis and molecular modeling) and its scheme can be applied to any other chemical substances, not only to aspirin.…”

Section: Methodsmentioning

confidence: 99%

From Synthesis and Spectral Analysis to Molecular Modeling – Multidimensional Teaching of Medicinal Chemistry: Aspirin as an Example

Polskia¹,

Kaczor²,

Sobotka-Polskad³

et al. 2015

IJPER

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Classical medicinal chemistry classes do not give satisfactory learning outcomes. Computing and communication technology have a great impact on all aspects of cognition, education and training. Thus, the field of computer-assisted science teaching is particularly active nowadays. Many authors reported that involving computers in education process makes it more interesting, develops motivation of the students and helps to keep their attention during classes. Using computers for teaching science is more and more common on all the levels of education, from primary to tertiary. In particular, computer-assisted classes may be of valuable help for the pharmacy or chemistry students who learn organic or medicinal chemistry. Therefore, the main objective of this study was to design modern and interesting medical chemistry computer-assisted laboratory for students. The proposed laboratory is a hybrid of both classic (synthesis of aspirin, TLC analysis, 1 H, 13C NMR and IR spectra) and new (molecular modeling) chemistry elements. We suggest a simple and safe method for the synthesis of aspirin and its analysis with spectroscopic methods. In addition, the laboratory includes the use of computational methods for the analysis of aspirin and its mechanism of action on the molecular level. These procedures are easy to use and can be easily carried out even by inexperienced students. Moreover, the proposed laboratory can be used as an example to create similar classes with the use of other drugs, it can be easily reproduced anywhere and does not require any special, expensive computer resources, being based on free and easy available software.

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Impurity profiling of pharmaceuticals by thin-layer chromatography

Cited by 29 publications

References 40 publications

Development of Quantitative HPTLC-Densitometry Methods Following a Model Approach for Transfer of TLC Screening Methods for Pharmaceutical Products of Metformin HCL, Potassium Clavulanate, Caffeine, Fluoxetine HCL, and Gabapentin

Development of Quantitative HPTLC-Densitometry Methods Following a Model Approach for Transfer of TLC Screening Methods for Pharmaceutical Products of Metformin HCL, Potassium Clavulanate, Caffeine, Fluoxetine HCL, and Gabapentin

A model procedure for the transfer of TLC pharmaceutical product screening methods designed for use in developing countries to quantitative HPTLC-densitometry methods

From Synthesis and Spectral Analysis to Molecular Modeling – Multidimensional Teaching of Medicinal Chemistry: Aspirin as an Example

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