Near-infrared spectroscopy (NIRS) and chemometric analysis of Malaysian and UK paracetamol tablets: A spectral database study

Mazlina Mohd Said, Simon Gibbons, Anthony C. Moffat, Mire Zloh

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

The influx of medicines from different sources into healthcare systems of developing countries presents a challenge to monitor their origin and quality. The absence of a repository of reference samples or spectra prevents the analysis of tablets by direct comparison. A set of paracetamol tablets purchased in Malaysian pharmacies were compared to a similar set of sample purchased in the UK using near-infrared spectroscopy (NIRS). Additional samples of products containing ibuprofen or paracetamol in combination with other actives were added to the study as negative controls. NIR spectra of the samples were acquired and compared by using multivariate modeling and classification algorithms (PCA/SIMCA) and stored in a spectral database. All analysed paracetamol samples contained the purported active ingredient with only 1 out of 20 batches excluded from the 95% confidence interval, while the negative controls were clearly classified as outliers of the set. Although the substandard products were not detected in the purchased sample set, our results indicated variability in the quality of the Malaysian tablets. A database of spectra was created and search methods were evaluated for correct identification of tablets. The approach presented here can be further developed as a method for identifying substandard pharmaceutical products.

Original languageEnglish
Pages (from-to)102-109
Number of pages8
JournalInternational Journal of Pharmaceutics
Volume415
Issue number1-2
DOIs
Publication statusPublished - 30 Aug 2011

Fingerprint

Near-Infrared Spectroscopy
Acetaminophen
Tablets
Databases
Passive Cutaneous Anaphylaxis
Pharmacies
Ibuprofen
Developing Countries
Spectrum Analysis
Confidence Intervals
Delivery of Health Care
Pharmaceutical Preparations

Keywords

  • Chemometrics
  • Counterfeit medicines
  • Malaysia
  • NIRS
  • Paracetamol
  • PCA
  • Qualitative study
  • SIMCA
  • Spectral database

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Near-infrared spectroscopy (NIRS) and chemometric analysis of Malaysian and UK paracetamol tablets : A spectral database study. / Mohd Said, Mazlina; Gibbons, Simon; Moffat, Anthony C.; Zloh, Mire.

In: International Journal of Pharmaceutics, Vol. 415, No. 1-2, 30.08.2011, p. 102-109.

Research output: Contribution to journalArticle

@article{3223a250dafd4430a947ca967fe8d6a7,
title = "Near-infrared spectroscopy (NIRS) and chemometric analysis of Malaysian and UK paracetamol tablets: A spectral database study",
abstract = "The influx of medicines from different sources into healthcare systems of developing countries presents a challenge to monitor their origin and quality. The absence of a repository of reference samples or spectra prevents the analysis of tablets by direct comparison. A set of paracetamol tablets purchased in Malaysian pharmacies were compared to a similar set of sample purchased in the UK using near-infrared spectroscopy (NIRS). Additional samples of products containing ibuprofen or paracetamol in combination with other actives were added to the study as negative controls. NIR spectra of the samples were acquired and compared by using multivariate modeling and classification algorithms (PCA/SIMCA) and stored in a spectral database. All analysed paracetamol samples contained the purported active ingredient with only 1 out of 20 batches excluded from the 95{\%} confidence interval, while the negative controls were clearly classified as outliers of the set. Although the substandard products were not detected in the purchased sample set, our results indicated variability in the quality of the Malaysian tablets. A database of spectra was created and search methods were evaluated for correct identification of tablets. The approach presented here can be further developed as a method for identifying substandard pharmaceutical products.",
keywords = "Chemometrics, Counterfeit medicines, Malaysia, NIRS, Paracetamol, PCA, Qualitative study, SIMCA, Spectral database",
author = "{Mohd Said}, Mazlina and Simon Gibbons and Moffat, {Anthony C.} and Mire Zloh",
year = "2011",
month = "8",
day = "30",
doi = "10.1016/j.ijpharm.2011.05.057",
language = "English",
volume = "415",
pages = "102--109",
journal = "International Journal of Pharmaceutics",
issn = "0378-5173",
publisher = "Elsevier",
number = "1-2",

}

TY - JOUR

T1 - Near-infrared spectroscopy (NIRS) and chemometric analysis of Malaysian and UK paracetamol tablets

T2 - A spectral database study

AU - Mohd Said, Mazlina

AU - Gibbons, Simon

AU - Moffat, Anthony C.

AU - Zloh, Mire

PY - 2011/8/30

Y1 - 2011/8/30

N2 - The influx of medicines from different sources into healthcare systems of developing countries presents a challenge to monitor their origin and quality. The absence of a repository of reference samples or spectra prevents the analysis of tablets by direct comparison. A set of paracetamol tablets purchased in Malaysian pharmacies were compared to a similar set of sample purchased in the UK using near-infrared spectroscopy (NIRS). Additional samples of products containing ibuprofen or paracetamol in combination with other actives were added to the study as negative controls. NIR spectra of the samples were acquired and compared by using multivariate modeling and classification algorithms (PCA/SIMCA) and stored in a spectral database. All analysed paracetamol samples contained the purported active ingredient with only 1 out of 20 batches excluded from the 95% confidence interval, while the negative controls were clearly classified as outliers of the set. Although the substandard products were not detected in the purchased sample set, our results indicated variability in the quality of the Malaysian tablets. A database of spectra was created and search methods were evaluated for correct identification of tablets. The approach presented here can be further developed as a method for identifying substandard pharmaceutical products.

AB - The influx of medicines from different sources into healthcare systems of developing countries presents a challenge to monitor their origin and quality. The absence of a repository of reference samples or spectra prevents the analysis of tablets by direct comparison. A set of paracetamol tablets purchased in Malaysian pharmacies were compared to a similar set of sample purchased in the UK using near-infrared spectroscopy (NIRS). Additional samples of products containing ibuprofen or paracetamol in combination with other actives were added to the study as negative controls. NIR spectra of the samples were acquired and compared by using multivariate modeling and classification algorithms (PCA/SIMCA) and stored in a spectral database. All analysed paracetamol samples contained the purported active ingredient with only 1 out of 20 batches excluded from the 95% confidence interval, while the negative controls were clearly classified as outliers of the set. Although the substandard products were not detected in the purchased sample set, our results indicated variability in the quality of the Malaysian tablets. A database of spectra was created and search methods were evaluated for correct identification of tablets. The approach presented here can be further developed as a method for identifying substandard pharmaceutical products.

KW - Chemometrics

KW - Counterfeit medicines

KW - Malaysia

KW - NIRS

KW - Paracetamol

KW - PCA

KW - Qualitative study

KW - SIMCA

KW - Spectral database

UR - http://www.scopus.com/inward/record.url?scp=79960157659&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79960157659&partnerID=8YFLogxK

U2 - 10.1016/j.ijpharm.2011.05.057

DO - 10.1016/j.ijpharm.2011.05.057

M3 - Article

C2 - 21645600

AN - SCOPUS:79960157659

VL - 415

SP - 102

EP - 109

JO - International Journal of Pharmaceutics

JF - International Journal of Pharmaceutics

SN - 0378-5173

IS - 1-2

ER -