Analysis of diltiazem in Lipoderm transdermal gel using reversed-phase high-performance liquid chromatography applied to homogenization and stability studies

J Pharm Biomed Anal. 2005 Jun 1;38(1):60-5. doi: 10.1016/j.jpba.2004.11.053. Epub 2004 Dec 25.

Abstract

A simple and novel method for the extraction and quantification of diltiazem hydrochloride was developed and applied to homogenization and stability studies. The method used solid phase extraction coupled with reversed-phase high-performance liquid chromatography (HPLC) with ultraviolet (UV) detection. Validation showed inter-day recoveries ranging from 84.00 to 96.52% with relative standard deviations ranging from 12.01 to 15.94%. Intra-day recoveries ranged from 67.95 to 106.1% with relative standard deviations less than 5%. The method showed excellent linearity from 50 to 250 mg/ml in undiluted gel (R2 = 0.996). The homogenization study showed good homogenization using both 50 and 100 depression techniques. Diltiazem was stable at a concentration of 246 mg/ml for 30 days and at a concentration of 99.6 mg/ml for 60 days no matter the storage conditions explored in this study.

Publication types

  • Validation Study

MeSH terms

  • Calcium Channel Blockers / analysis*
  • Chromatography, High Pressure Liquid / methods*
  • Diltiazem / analysis*
  • Drug Stability
  • Gels
  • Pharmaceutical Preparations / chemistry*
  • Reference Standards
  • Reproducibility of Results

Substances

  • Calcium Channel Blockers
  • Gels
  • Pharmaceutical Preparations
  • Diltiazem