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.

Abstract

To assess the quality of cotrimoxazole tablets produced by a Tanzanian manufacturer by a newly instituted quality assurance programme. 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). Based on results from the primary test methods, the first group of product was <80% compliant, whereas subsequent groups reached >99% compliance. 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.