Abstract
Author(s): Muralee Krishna, Meghana Nadre, Anirudhha Sherikar, Ranjith Reddy
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 on LiChrospher, 100 RP-18 end capped, 4mm x 12.5 cm, 5µm column 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 guideline by High performance liquid chromatography
