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.
A reverse phase high pressure liquid chromatographic method in which ion-pairing is used for the determination of combinations of pseudoephedrine hydrochloride with triprolidine hydrochloride or chlorpheniramine maleate in syrups and tablets was collaboratively studied by 8 laboratories. Collaborators were supplied with 12 samples including synthetic and commercial syrup formulations and commercial tablet composites. Mean recoveries of pseudoephedrine hydrochloride and triprolidine hydrochloride from synthetic syrup formulations were 100.5 and 99.6%, respectively. Mean recoveries of pseudoephedrine hydrochloride and chlorpheniramine maleate from synthetic syrups were 98.8 and 100.5%, respectively. Mean coefficients of variation for syrups and tablets ranged from 1.68 to 3.07% for pseudoephedrine hydrochloride, from 2.92 to 3.85% for triprolidine hydrochloride, and from 1.34 to 2.15% for chlorpheniramine maleate. The method has been adopted official first action.
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