Author:
Saad Marwa T.,Zaazaa Hala E.,Fattah Taghreed A.,Boltia Shereen A.
Abstract
AbstractAn economical & eco-friendly spectrofluorometric method has been developed for the determination of prucalopride succinate (PRU) in human urine on the basis of the drug’s native fluorescence. The type of solvent and the wavelengths of excitation and emission have been carefully selected for optimal experimental conditions. In deionized water, the fluorescence intensity was measured at λ emission 362 nm upon excitation at 310 nm. This bio-validated method was carried out using 30uL urine without any preliminary steps. The calibration curve for prucalopride succinate shows a linear relationship in a concentration range of 0.75–5.5 µg/mL. Accuracy and precision were obtained using 4 quality control samples which are: 0.75 μg/ mL (LLOQ), 2.25 μg/mL (QCL), 2.5 μg/mL (QCM) & 4.125 µg/mL (QCH). The validation of this proposed technique obeys European Medicines Agency (EMA) Guidelines for validating bioanalytical methods and the greenness assessment was evaluated according to the Analytical GAPI approach.
Publisher
Springer Science and Business Media LLC
Subject
Law,Clinical Biochemistry,Spectroscopy,Sociology and Political Science,Social Sciences (miscellaneous),Clinical Psychology,Biochemistry
Reference19 articles.
1. Kaza M, Karaźniewicz-Łada M, Kosicka K, Siemiątkowska A, Rudzki PJ (2019) Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse? J Pharm Biomed Anal 165:381–5
2. https://pubchem.ncbi.nlm.nih.gov/compound/Prucalopride-succinate. Access at (11/9/2019)
3. Smith WB, Mannaert E, Verhaeghe T, Kerstens R, Vandeplassche L, Van de Velde V (2012) Effect of renal impairment on the pharmacokinetics of prucalopride: a single-dose open-label phase I study. Drug Des Dev Ther 6:407
4. Vaibhavi N, Akhani KKP, Patel KS, Prajapati LM, Patel CN (2020) Development & Validation of RP-HPLC method for estimation of prucalopride succinate in pharmaceutical dosage form. WORLD J Pharm Pharm Sci. 9(6):1112–22
5. Kanthale SB TS, Pekamwar SS, Mahapatra DK (2020) Development and validation of a stability indicating Rp-Hplc method for the determination of prucalopride succinate in bulk and tablet. Int J Pharm Sci Drug Res 12(2):166–74
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