Determination of temazepam and related compounds in capsules by high-performance liquid chromatography.
A reversed-phase, high-performance liquid chromatographic assay method is described for temazepam hard gelatin and soft gelatin capsule analysis. The method is simple, specific, accurate, fast, and stability indicating. A reversed-phase octylsilane (C8) column with a mobile phase composed of methanol:1% acetic acid and detection at 254 nm separated sulfanilamide (internal standard), temazepam, synthetic precursor, and possible degradation products. Detector responses showed linearity to temazepam concentrations over the range 0.075-0.60 mg/mL (r = 0.9999). Mean recovery of temazepam added to capsule excipients was 100.3%. Mean assay results for 15- and 30-mg hard gelatin capsules were 101.5 and 101.3%, respectively. Mean assay results for 10- and 20-mg soft elastic gelatin capsules were 101.1 and 101.5%, respectively.
D014151:Anti-Anxiety Agents / Q000032:analysis*; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D012996:Solutions; D013693:Temazepam / Q000032:analysis*
D014151:Anti-Anxiety Agents; D002214:Capsules; D012996:Solutions; D013693:Temazepam