Abstract
A simple and fast analytical method of ultra-high performance liquid chromatography (UHPLC) was developed and validated in order to assay isradipine in poly(ε-caprolactone) (PCL)/polyethylene glycol (PEG) nanocapsules. Experiments were performed by UHPLC on a C18 chromatographic column at 25°C using a mobile phase composed by methanol and water (85:15 v/v) with a flow rate of 0.5 mL.min−1 and UV detection at 327nm for achieving a total run time of 1.5 min. The UHPLC method was validated according to the guidelines set on The International Conference on Harmonisation. It proved to be selective, linear (r = 0.99962), precise (RSD < 4.1%), and accurate (recovery rates between 95.24 and 96.53%) at the range from 10 to 40 µg.mL−1. The performance was robust when slight changes in the flow rate, wavelength of detection, and mobile phase composition were tested. It was successfully applied to quantify isradipine from nanoparticulate polymeric systems, showing high loading efficiency rates, greater than 98.55%. These results provided an experimental basis to use this method for quantifying isradipine with reliable results, besides being very fast, easy to perform and cheaper.
Highlights
Quality control has been an essential tool for pharmaceutical industries since it ensures efficacy and safety for pharmaceutical products
The validation of an analytical method is a major approach for assuring its quality, especially when the need to prove the quality of pharmaceutical analysis has been increasingly recognized and demanded since unreliable data can lead to wrong decisions and irrecoverable financial losses [2]
The isradipine (ISR) or 3-methyl 5-propan-2-yl 4-(2,1,3-benzoxadiazol4-yl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate is a calcium channel blocker which belongs to the dihydropyridine class and has demonstrated an interesting neuroprotective effect associated to its pharmacotherapeutic use [4]
Summary
Quality control has been an essential tool for pharmaceutical industries since it ensures efficacy and safety for pharmaceutical products. The validation of an analytical method is a major approach for assuring its quality, especially when the need to prove the quality of pharmaceutical analysis has been increasingly recognized and demanded since unreliable data can lead to wrong decisions and irrecoverable financial losses [2]. In this sense, ultra-high performance liquid chromatography (UHPLC) brought new opportunities in pharmaceutical industries to get faster analytical separation results while remaining the method quality. The research for strategies that make it possible to deflect the limitations related to the action of this drug in the central nervous system is growing and current
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