Abstract

ANALYTICAL METHODS DEVELOPMENT AND VALIDATION OF DROXIDOPA

Ankit B. Chaudhary*, Ritu D. Patel and Monica J. Hingu

ABSTRACT

One simple, specific, accurate, precise method have been developed and validated for the estimation of droxidopa. Chemically (2S,3R)-2amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid C9H11NO5 [Fig.1]. In High Performance Liquid Chromatography Method the chromatographic system was equipped with Thermohypersil C8 column (150mm x 3.20 mm, 5μ) as stationary phase and UV detector set at 220 nm, in conjunction with a mobile phase of Methanol: Water 60:40% v/v ratio at a flow rate of 0.5ml/min. The described method was linear over a concentration range of 50-150 μg/ml for droxidopa. The retention time of Droxidopa is 3.560 min. The % recovery of Droxidopa were found to be 101.53 % - 102.64 % respectively. Method were statistically validated for accuracy, precision, specificity, LOD and LOQ according to ICH guidelines and can be used for analysis. Method were statistically validated for accuracy, precision, specificity, LOD and LOQ according to ICH guidelines and can be used for analysis. Forced degradation study of droxidopa is carried out in that acid, alkali, peroxide and thermal degradation. The propose method enables rapid quantification and simultaneous analysis of drug from syrup without any interference of excipients. So, the method can be used for routine analysis.

Keywords: Droxidopa, HPLC Method, Forced degradation.