Three techniques for the determination of perindopril through derivatization with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole

Abstract

In addition to its pure form, three accurate, rapid, and simple methods have been established for determining perindopril (PRD) in its tablet form. At pH 9.0 using a borate buffer, developing the three designated methods was successful according to the reaction between PRD and 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) and the formation of a chromogen (with a yellow color) measurable at 460 nm using the spectrophotometric method (Method I). In addition, the produced chromogen was assessed using the spectrofluorimetric method (Method II) at 535 nm following excitation at 461 nm. Afterward, the same reaction product was separated and determined using the HPLC method with fluorescence detection (Method III). A Promosil C18 stainless steel column (Q7 5 mm particle size, 250–4.6 mm) has proven suitable for separation. The mobile phase adjustment was made at pH 3.0, with a 1.0 mL min −1 flow rate; its composition was methanol-sodium dihydrogen phosphate, 0.02 M (60: 40, v/v). Through concentration ranges of 5.0–60.0, 0.5–6.0, and 1.0–10.0 μg mL−1, the calibration curves were rectilinear for Methods I, II, and III, respectively, with limits of quantification (LOQ) of 1.08, 0.16 and 0.19 μg mL−1 as well as limits of detection (LOD) of 0.36, 0.05 and 0.06 μg mL−1. The developed methods were implemented to estimate PRD in tablets, and a comparison between the obtained outcomes utilizing the developed methods as well as obtained from the official method revealed that they were comparable. The official BP method was based on dissolving PRD in anhydrous acetic acid and titrating with 0.1 M perchloric acid, then the potentiometric determination of the end-point. The designated methods were also implemented in content uniformity testing with satisfying results. The reaction pathway proposal was speculated, and according to ICH Guidelines, the statistical evaluation of the data was performed. The three proposed methods were confirmed to be green, eco-friendly and safe to environment using Green Analytical procedure index (GAPI) method.

Development of fluorescence probe for spectrofluorimetric determination of viloxazine hydrochloride in pharmaceutical form and rat plasma; additional pharmacokinetic study

“…NBD-Cl serves as a fluorogenic agent implemented as a fluorescence probe to determine drugs that possess primary and secondary amine groups [22][23][24][25][26][27][28][29]. The interaction between NBD-Cl and the amine moiety of the drugs at an alkaline pH level modifies the polarization of its chromophore system and generates adducts that are highly fluorescent.…”

Concepts for a New Rapid and Simple HPLC Method for Simultaneous Determination of Rosuvastatin and Perindopril in Dosage Forms

“…Other metabolites do not demonstrate activity in the inhibition of ACE under experimental conditions [28]. The analytical methods for the determination of perindopril in its pure or dosage forms comprise spectrophotometry [29][30][31][32][33][34][35][36][37][38][39][40][41][42], spectrofluorimetry [43][44][45], HPLC [40][41][42][46][47][48][49][50][51][52][53][54][55][56][57][58][59][60], and so on. Anwar S. et al published an article in 2020 about the development and in vitro characterization of rosuvastatin, perindopril, and ezetimibe-loaded instant release buccal films from the pharmaceutical technology aspect [60]; however, this method has some drawbacks: It has not achieved and presented resolution between the first two peaks approaching the void volume of the column, and the bad-shaped "finger-type" peak apex of the last eluting rosuvastatin is due to the approaching solubility limit in the phosphate salt buffered mobile phase, thus reducing accuracy, sensitivity and simplicity, and rapidity of the method.…”