ANALYTICAL METHOD VALIDATION FOR DETERMINATION OF RELATED SUBSTANCES OF DEXMEDETOMIDINE (IMPURITY-1) IN DEXMEDETOMIDINE HYDROCHLORIDE INJECTIONAbstract
Dexmedetomidine, approved by the Food and Drug Administration (FDA) in 1999 as a sedative for use in the intensive care unit, is a potent and highly selective α2-adrenoceptor agonist with significant sedative, analgesic and anxiolytic effects mostly used in the intensive care units. This article describes validation for determination of related substances of dexmedetomidine (impurity-1) in dexmedetomidine hydrochloride injection by using a high performance liquid chromatography. The high performance liquid chromatography resolution was achieved on an Phenomenex Luna C18 (2) 150 x 4.6 mm, column with an isocratic elution at a flow rate of 1.0 mL/min using a mobile phase of75-25% of Buffer with Acetonitrile. The detection was performed by a photo diode array Detector. The method was validated in the concentration range of 0.003 ppm (Limit of quantification) to 0.06 ppm (150%). The intra and inter-day precision and accuracy were within Limit (10 % RSD). The overall mean recoveries of Dexmedetomidine were 97.5% for Limit of Quantitation and 95.6 % for 50% to 150%.
Muralee Krishna, Meghana Nadre, Anirudhha Sherikar and Ranjith Reddy *
Glenmark pharmaceutical Limited, Pithampur, Madhya Pradesh, India
10 June, 2015
15 July, 2015
03 October, 2015
01 December, 2015