Abstract

DEVELOPMENT & VALIDATION OF ENANTIOMERIC PURITY METHOD FOR ANTI ASTHMATIC DRUG SUBSTANCES BY SUPERCRITICAL FLUID CHROMATOGRAPHY

Pralhad Rege*, Vaibhav Wagh and Ravi Gowda

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Abstract

In the present study, a successful attempt has been made to develop the simultaneous determination of Enantiomeric impurities in Levosalbutamol by using a simple, cost effective, sensitive, accurate and precise high performance liquid chromatographic method. Acquity Trefoil CEL2, 15cm x 3.0mm, 2.5 μ in gradient mode, with Gradient mobile phase, Mobile Phase A: Liquid Carbon Dioxide and Mobile Phase B: Methanol: Isopropyl alcohol: Trifluroacetic acid: Diethylamine was used in ratio of (50:50:0.1:0.1). A flow rate of 2.5 mL/min and detection was carried out at 225 nm. The retention time is 2.0 min. The method is validated by determining its sensitivity, precision, linearity, accuracy. The proposed method is simple, rapid, sensitive, accurate and precise and so that it can be applied for routine quality control analysis of Levosalbutamol drug substance.

Keywords: HPLC, Levosalbutamol sulphate, Methanol, Diethylamine, Trifluroacetic acid, Isopropyl alcohol and Enantiomeric impurities.