Thiopental sodium is a medicine given intravenously to induce short duration general anaesthesia. The content of active pharmaceutical ingredients and related substances should be strictly controlled for injected drugs. This application shows a method for the simultanious determination of thiopental and related substances. ASTRA® column allows all impurities to separate according to the method and provides an accurate and robust determination of thiopental.
ABSTRACT
Isocratic HPLC/UV method for the simultaneous determination of thiopental sodium (CAS 71-73-8) and its related substances, on an ASTRA® C18-HE, 5 µm column (150 mm × 4.6 mm, AST-5732-LK46). Mobile phase 0.02M H3PO4 : ACN 65/35 (v/v), flow rate 1.0 ml/min, temperature 25 °C, injection volume 10 µL, UV detection at 225 nm. Impurities A, B and C elute between about 7 and 12 minutes and impurity D at about 29 minutes around the main thiopental peak at about 23 minutes. Developed in co-operation with VUAB Pharma, a.s.
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Impurity ACAS number not available
Impurity BCAS number not available
Impurity CCAS number not available
Thiopental sodiumCAS number 71-73-8
Impurity DCAS number not available
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VUAB Pharma, a.s.
Czech pharmaceutical company named in the ASTRA(R) application note on thiopental impurities as the co-operating partner for the simultaneous determination of thiopental sodium and its related substances.
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