Characterization and HPLC Method Validation for Determination of Dopamine Hydrochloride in Prepared Nano Particles and Pharmacokinetic Application

Abstract

The emotional control monoamines neurotransmitter catecholamine group of chemicals is dopamine. It has been described and recognized that a lack of dopamine containing neurons contributes to neurological issues, such as Parkinsonism. Due to the incapability of dopamine HCl to cross the blood brain barrier, the advanced novel drug delivery of dopamine HCl is performed in the form of nano structure lipid carrier system (NLC-DOPA) to bypass the blood brain barrier using intranasal route of administration with improved compliance bioavailability and less side effect. The NLC-DOPA was prepared by the high pressure homogenizer ultra-probe sonicator and characterized by the particle size analyzer, zeta potential, transmission electron microscopy (TEM) and X-Ray diffraction (XRD). The determination of dopamine hydrochloride in formulation was evaluated by drug entrapment efficiency further it is validated by analytical method development using high performance liquid chromatography (HPLC) with C18 ODS column and 0.05 M KH₂PO₄ buffer pH 2.5 and Methanol (90:10) along with retention time 4.872 min at 280 nm wavelength. The method was validated for dopamine HCl in formulation with linearity, precision and recovery analysis. The study was shown that method was easy, rapid, accurate, specific and precise for quality analysis of dopamine HCl in NLC-DOPA formulation. The validated method of HPLC was further used for the biological application in term of the pharmacokinetic study to find out the concentration of drug in blood as well as brain. The pharmacokinetic parameters were calculated with help of the software PK solver 2.0 to determine the maximum concentration (C_max), Maximum time (T_max), Elimination half life (t_1/2), Area under the curve (AUC_0-t), volume of distribution (Vz/F_obs) and Clearance (Cl/F_obs) of all groups of animals (n=3). The study showed that the NLC-DOPA was producing a sustained and controlled release in appropriate amount of drug through intranasal bypass delivery into brain.

GRAPHICAL ABSTRACT

Keywords:

• Nano structure lipid carrier
• Zeta sizer
• Transmission electron microscopy
• X-ray diffraction
• Homogenization
• Validation
• Chromatogram
• Analysis
• Pharmacokinetic study