Stability-indicating assay for chlorthalidone formulation: evaluation of the USP analysis and a high-performance liquid chromatographic analysis

J Pharm Sci. 1983 Aug;72(8):924-8. doi: 10.1002/jps.2600720821.

Abstract

An investigation of the USP assay of chlorthalidone tablets showed that variable degradation of chlorthalidone occurred during assay preparation. The degradation products were isolated and identified. A stability-indicating high-performance liquid chromatographic (HPLC) assay which separates the degradation products from chlorthalidone was developed and used to examine the present USP preparation. The HPLC assay is suggested as an alternate.

MeSH terms

  • Chlorthalidone / analysis*
  • Chromatography, High Pressure Liquid / methods
  • Drug Stability
  • Pharmacopoeias as Topic
  • Tablets / analysis
  • Time Factors
  • United States

Substances

  • Tablets
  • Chlorthalidone