Chromatographic impurity fingerprinting of genuine and counterfeit Cialis® as a means to compare the discriminating ability of PDA and MS detection

Custers, D.; Krakowska, B.; Beer, Jacques O. De; Courselle, P.; Daszykowski, M.; Apers, Sandra; Deconinck, Éric

doi:10.1016/j.talanta.2015.09.029

Cited by 24 publications

(9 citation statements)

References 17 publications

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“…Inertsil ODS-3V Column 250 mm×4.6 mm ID, 5 µm dp [57] Grace Alltima C18 Column 250 mm×3 mm ID, 5 µm dp [58] Macherey-Nagel Nucleosil C18 Column 150 mm×4.6 mm ID, 5 µm dp…”

Section: Gl Sciencesmentioning

confidence: 99%

Application of Liquid Chromatography Coupled With Mass Spectrometry in the Impurity Profiling of Drug Substances and Products

Akshatha

Gurupadayya

2018

Asian J Pharm Clin Res

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As the drug safety and efficacy is hampered in the presence of an impurity, the international regulatory agencies laid down stringent limits for the control of impurities in the active pharmaceutical ingredient and pharmaceutical formulations. The conventional approaches lack the characterization of impurities in trace levels, due to sensitivity issues, hyphenated techniques are preferred. Among the modern hyphenated techniques, liquid chromatography-mass spectrometry (LC-MS) has high sensitivity and can analyze large number of organic compounds in a short period of time. In the present study, the impurity profiling of various drug substances and products using LC-MS about past 6 years were retrospect for its importance, instrumentations, and applications.

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“…Inertsil ODS-3V Column 250 mm×4.6 mm ID, 5 µm dp [57] Grace Alltima C18 Column 250 mm×3 mm ID, 5 µm dp [58] Macherey-Nagel Nucleosil C18 Column 150 mm×4.6 mm ID, 5 µm dp…”

Section: Gl Sciencesmentioning

confidence: 99%

Application of Liquid Chromatography Coupled With Mass Spectrometry in the Impurity Profiling of Drug Substances and Products

Akshatha

Gurupadayya

2018

Asian J Pharm Clin Res

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“…[3][4][5] For this purpose, the techniques that have been proposed are generally classified into chromatographic and spectroscopic methods. [6][7][8] Spectroscopic techniques present the advantage to be often non-destructive, the need of little sample preparation and short time analysis. In general, these methods are preferred for the identification of counterfeit drugs or to achieve high sample throughput.…”

Section: Introductionmentioning

confidence: 99%

“…In general, these methods are preferred for the identification of counterfeit drugs or to achieve high sample throughput. [7,9] In regard to spectroscopy, the high suitability of nuclear magnetic resonance spectroscopy (NMR) for a quality assessment of drugs and excipients has been reported. Moreover, quantitative NMR (qNMR) has been indicated as appropriate for quantification of the components without previous separation.…”

Section: Introductionmentioning

confidence: 99%

“…Some of these studies also recently published focus on the importance of an alternate approach, fast and reliable analytical tools and inexpensive technique, high throughput and high performance analysis to identify products, distinguish between good quality and low quality of drug and speed up the investigations [3–5] . For this purpose, the techniques that have been proposed are generally classified into chromatographic and spectroscopic methods [6–8] . Spectroscopic techniques present the advantage to be often non‐destructive, the need of little sample preparation and short time analysis.…”

Section: Introductionmentioning

confidence: 99%

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Rapid Approach for Pharmaceutical Quality Evaluation and Comparison

2022

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A rapid approach, with the association of Fourier‐transform infrared spectroscopy (FTIR) and nuclear magnetic resonance spectroscopy (NMR), is proposed in order to provide a fast quality evaluation of pharmaceutical products. It offers an analytical screening tool also useful to compare drug products including generics. The approach requires a minimal amount of solvents and little sample preparation. In this paper characterization of pharmaceutical product samples containing telmisartan, allopurinol, anastrozole, metformin hydrochloride and lamivudine, active pharmaceutical ingredients (APIs) in solid dosage forms, are reported. The results show how this approach can provide useful data for a rapid screening of pharmaceutical composition and comparison of drugs with useful information also in terms of equivalence risk analysis.

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“…Thus, they can be adopted to identify substandard products. Possible issues include 1) out-of-specification content of active pharmaceutical ingredient (API), 24,25 2) significant dissolution delay, 24 3) contamination with toxic substances, 26,27 and 4) lack of sterility. 28,29 These points can be checked by means of assay, content uniformity testing, measurements of dissolution properties and impurities, and microbial tests.…”

Section: Introductionmentioning

confidence: 99%

Survey to Identify Substandard and Falsified Tablets in Several Asian Countries with Pharmacopeial Quality Control Tests and Principal Component Analysis of Handheld Raman Spectroscopy

Kakio

Nagase

Takaoka

et al. 2018

The American Journal of Tropical Medicine and Hygiene

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The World Health Organization has warned that substandard and falsified medical products (SFs) can harm patients and fail to treat the diseases for which they were intended, and they affect every region of the world, leading to loss of confidence in medicines, health-care providers, and health systems. Therefore, development of analytical procedures to detect SFs is extremely important. In this study, we investigated the quality of pharmaceutical tablets containing the antihypertensive candesartan cilexetil, collected in China, Indonesia, Japan, and Myanmar, using the Japanese pharmacopeial analytical procedures for quality control, together with principal component analysis (PCA) of Raman spectrum obtained with handheld Raman spectrometer. Some samples showed delayed dissolution and failed to meet the pharmacopeial specification, whereas others failed the assay test. These products appeared to be substandard. Principal component analysis showed that all Raman spectra could be explained in terms of two components: the amount of the active pharmaceutical ingredient and the kinds of excipients. Principal component analysis score plot indicated one substandard, and the falsified tablets have similar principal components in Raman spectra, in contrast to authentic products. The locations of samples within the PCA score plot varied according to the source country, suggesting that manufacturers in different countries use different excipients. Our results indicate that the handheld Raman device will be useful for detection of SFs in the field. Principal component analysis of that Raman data clarify the difference in chemical properties between good quality products and SFs that circulate in the Asian market.

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Chromatographic impurity fingerprinting of genuine and counterfeit Cialis® as a means to compare the discriminating ability of PDA and MS detection

Cited by 24 publications

References 17 publications

Application of Liquid Chromatography Coupled With Mass Spectrometry in the Impurity Profiling of Drug Substances and Products

Application of Liquid Chromatography Coupled With Mass Spectrometry in the Impurity Profiling of Drug Substances and Products

Rapid Approach for Pharmaceutical Quality Evaluation and Comparison

Survey to Identify Substandard and Falsified Tablets in Several Asian Countries with Pharmacopeial Quality Control Tests and Principal Component Analysis of Handheld Raman Spectroscopy

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