Development and Validation of a Stability Indicating RP-HPLC Method for the Determination of Prucalopride succinate in Bulk and Tablet

Abstract

A very simple, precise, economical, accurate, robust, and reproducible reverse phase-high-performance liquid chromatography method along with stability indicating attributes has been developed for estimating of prucalopride succinate (PRU) in both bulk and tablet formulation (PRUVICT 2). The estimation of the solutes was performed on a Grace C18 column of dimension 150 mm × 4.6 mm, 5 μm. PRU was eluted with acetonitrile: 0.02 M potassium dihydrogen phosphate in the ratio of 20:80 v/v in a 10 min isocratic mode at a flow rate of 1 ml/min at 30°C column temperature and monitored at a wavelength of 277 nm. The retention time of PRU was found to be 5.416 minutes. The Q2b validation of the analytical method revealed good linearity over the concentration range 2–12 μg/mL for IVA with r2 of 0.999. The mean recovery % over the three tested ranges of 50%, 100%, and 150% were found to be 100.173%, 99.077%, and 98.575%, respectively. In intra-day variability study, the % RSDs was detected to be 0.754, 1.032, and 0.482 whereas the inter-day variability study demonstrated % RSDs of 0.797, 0.559, and 0.524, respectively. The acid, alkali, boiled water, hydrogen peroxide, dry heat, and UV radiations based stress studies presented the formation of a variety of characteristic degradation products. The developed analytical method may be employed for the routine analysis of PRU in bulk and tablet formulations.

Novel sensing probe using Terbium-sensitized luminescence and 8-hydroxyquinoline for determination of prucalopride succinate: green assessment with Complex-GAPI and analytical Eco-Scale

“…The method was successfully applied to determine the studied drug in pharmaceutical tablet dosage form; the recoveries obtained are summarized in Table 4 . The proposed method showed good agreement when compared with the reference method [ 10 ] regarding accuracy as indicated by the student’s t -test and precision as indicated by the F-test [ 23 ].…”

“…Herein, we aimed to use the advantage of the lanthanide-sensitized luminescence to develop and validate an analytical method for the determination of prucalopride succinate (PRU). The IUPAC name of PRU is 4-amino-5-chloro-N-[1-(3-methoxypropyl)piperidin-4-yl]-2,3-dihydro-1-benzofuran-7-carboxamide;butanedioic acid [ 10 ] (Fig. 1 ).…”

“…The drug was approved to be used in USA for the first time in 2018 after approval from FDA but it was previously approved in Europe in 2009 [ 11 ]. By surveying the literature for the developed methods for determination of PRU and to the best of our knowledge, we found few methods for the drug analysis; spectrophotometric methods [ 12 , 13 ] and chromatographic methods [ 10 , 14 – 16 ].

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Bioanalytical Validated Spectrofluorimetric Method for the Determination of Prucalopride succinate in Human Urine Samples and Its Greenness Evaluation

“…The literature review revealed the determination of PRU using various analytical techniques including chromatographic [4][5][6][7][8][9][10], spectrophotometric [11] methods and only one reported spectrofluorometric procedure that uses luminescence reaction [12] but there is no quantification in the urine sample. Spectrofluorimetric technique is commonly used in drugs analysis either in dosage form or in biological fluids for its high sensitivity and simplicity [13][14][15].…”

Bioanalytical validated Spectrofluorimetric Method for the Determination of Prucalopride succinate in Human Urine Samples and Its Greenness Evaluation

“…Literature review revealed the determination of PRU using various analytical techniques including chromatographic [3][4][5][6][7][8][9] , spectrophotometric 10 methods and only one reported spectro uorometric procedure that use luminescence reaction 11 but there is no quanti cation in the urine sample. By taking the bene t of native uorescence of PRU; the proposed method is aimed at developing an easy and rapid assay method for the quantitative determination of PRU in human urine without any time-consuming sample preparation steps for routine analysis.…”