Liquid Chromatographic Determination of Flurazepam Hydrochloride in Bulk Drug and Dosage Forms: Collaborative Study

Abstract

Eleven laboratories collaboratively studied the liquid chromatographic method for determining flurazepam hydrochloride In capsules and bulk drug. The method uses an octadecylsllane reversed- phase column, a mobile phase of methanol- 1% ammonium acetate (80 + 20), and photometric detection at 239 nm. Each collaborator received 8 samples: powdered composites of 5 commercial capsule preparations, each as a blind duplicate pair, and 3 bulk drug samples (1 blind duplicate). The ranges of repeatability and reproducibility relative standard deviations were 0.93-2.46 and 2.42-3.86% for the capsule samples and 0.97 and 1.76-2.27% for the bulk drug samples, respectively. The method was adopted first action by AOAC International.