Accurate and efficient analytical methods that can facilitate the formulation development and evaluation process are essential. This targeting approach is receiving increased attention for the development of highly efficacious therapeutics with minimal side effects that can be used in a wide range of diseases where ideal pharmaceutical options are currently limited. The targeting ability of NPs is influenced by surface ligands that interact specifically at receptors on the target site. NPs act as a drug carrier to provide targeted delivery of a concentrated payload to, and sustained release at, the target site for therapeutic action. To overcome the challenge of RHT transport into the brain, it has been formulated into nanoparticles (NPs) since 2008. Like other CNS drugs, treatment efficacy of RHT is primarily restricted, not by the drug’s inherent potency but by its ability to cross the blood-brain barrier (BBB) into the brain due to its hydrophilic nature. However, the current therapeutic regimen of RHT demands frequent dosing, and cholinergic side effects are common. It is commercially available as capsules, oral solution, and patches. RHT has been reported to improve or maintain patients’ cognitive function, global function, behaviour, and day-to-day activities. RHT increases the central cholinergic function by enhancing the ACh level in mild-to-moderate AD patients and inhibits deposition of amyloid plaques in the brain, slowing down the mental decline. Among the many chemical changes that the brain encounters during AD, depletion of ACh is one of the earliest and biggest changes. RHT is a cholinesterase inhibitor that inhibits both acetylcholinesterase (AChE) and butyrylcholinesterase (BuChE) enzymes responsible for the degradation of acetylcholine (ACh) into nonfunctional metabolites. Rivastigmine hydrogen tartrate (RHT) was approved by the US FDA in 2000 for the treatment of mild-to-moderate dementia of either Alzheimer’s type or related to Parkinson’s disease. Consequently, there is an increase in demand for effective treatments for these diseases. There is a worldwide increase in the prevalence of brain diseases such as Alzheimer’s disease (AD), Parkinson’s disease, and stroke due to the increase of the aging population. This stability indicating HPLC method was selective, accurate, and precise for analysing RHT loading and its stability in nanoparticle formulation, RHT release, and cell transport medium. The method was rugged with good intra- and interday precision. The limit of detection (LOD) and limit of quantification (LOQ) of the assay were 60 ng/mL and 201 ng/mL, respectively.
HOW TO DETERMINE PEAK PURITY IN AGILENT CHEMSTATION FREE
The RHT peak detected in the samples of a forced degradation study, drug loading study, release study, and cellular transport study was pure and free of matrix interference. The recovery (accuracy) of RHT from all matrices was greater than 99.2%.
This HPLC method exhibited good linearity, accuracy, and selectivity. Analyses were carried out at a flow rate of 1.5 mL/min at 50☌ and monitored at 214 nm. An isocratic HPLC analysis method using a reverse phase C 18 column and a simple mobile phase without buffer was developed, optimised, and fully validated. The objective of this study was to develop and validate a method for quantitative analysis of rivastigmine hydrogen tartrate (RHT) in dual-ligand polymeric nanoparticle formulation matrices, drug release medium, and cellular transport medium.
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