Implementation of 350-2500 nm Diffuse Reflectance Spectroscopy and High Performance Thin Layer Chromatography to Rapidly Assess Manufacturing Consistency and Quality of Cotrimoxazole Tablets in Tanzania

Journal Article
  • Eliangiringa Kaale
  • Samuel M. Hope
  • David W. Jenkins
  • Thomas Layloff
Tropical Medicine and International Health
Oct. 12, 2015. DOI: 10.1111/tmi.12621.

Abstract

OBJECTIVE:

To assess the quality of cotrimoxazole tablets produced by a Tanzanian manufacturer by a newly instituted quality assurance program.

METHODS:

Tablets underwent a diffuse reflectance spectroscopy procedure with periodic quality assessment confirmation by assay and dissolution testing using validated HPTLC techniques (including weight variation and disintegration evaluations).

RESULTS:

Based on results from the primary test methods, the first batch of product was <80% compliant, whereas subsequent batches reached >99% compliance.

CONCLUSIONS:

This approach provides a model for rapidly assuring product quality of future procurements of other products that is more cost effective than traditional pharmaceutical testing techniques. 

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