Research Article
Open Access
Stability indicating HPLC Method Validation for the Assay of Dexmedetomidine in Dexmedetomidine Hydrochloride Injection
Muralee Krishna, Meghana Nadre, Anirudhha Sherikar, Ranjith Reddy*
Glenmark Pharmaceutical Limited, Pharma zone, Pithampur (INDIA)-454775
Ranjith Reddy et al /Int.J. TechnoChem Res. 2016,2(1),pp 54-61.
Abstract
A simple, accurate, rapid and precise High performance liquid chromatographic (HPLC)
method was validated for the determination of Assay of dexmedetomidine in dexmedetomidine
hydrochloride injection.The method employs Waters HPLC system onLiChrospher, 100 RP-18 end
capped, 4mm x 12.5 cm, 5µmcolumn with an isocratic elution at a flow rate of 1.0 mL/min using a
mobile phase of 60-40% of methanol and Buffer. The detection was performed by a photo diode array
Detector. In Linearity over concentration range of 50% to 150% correlation observed was 0.999. The
intra and inter-day precision are with in limit (overall % RSD not more than 2.0 %). The overall mean
recovery over a range 80,100, 120 %of Dexmedetomidine was 101.1%. The method is robust even for
slight change in chromatographic conditions. Dexmedetomidine in this study complied with the
pharmacopeial limits. The validated method was Specific, Linear, Precise, Accurate, Rugged and
Robust for Assay of Dexmedetomidine in Dexmedetomidine HCl injection.The method validated as
per ICH guidelineby High performance liquid chromatography.
Keywords
Dexmedetomidine, Validation, Assay,High performance Liquid Chromatography
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