A Validated Stability-Indicating Method for Separation of Prucalopride Drug by HPLC: Method Transfer to UPLC. Issue 4 (4th July 2021)

• Record Type: Journal Article
• Authors: Makwana, Sheetal; Patil, Veerabhadragouda B.; Patel, Madhavi; Upadhyay, Jatin; Shah, Anamik
• Is Part Of: Analytical chemistry letters. Volume 11:Issue 4(2021)
• Page Start: 580
• Page End: 595
• Publication Date: 2021-07-04
• Subjects: Validation -- Significance of Method transfer -- Sensitive detection limit -- Stability indicating method; Chemistry, Analytic -- Periodicals; 543.05
• DOI: 10.1080/22297928.2021.1911680
• Languages: English
• ISSNs: 2229-7928

Abstract

Abstract: The presented research work is based on a quick study of Prucalopride succinate (PRS) by a novel approach of method transfer from High-Performance Liquid Chromatography to Ultra Performance Liquid Chromatography by using UV and PDA detector, respectively; with detailed forced degradation study with its significance. The validation study was carried out for the pure, active pharmaceutical ingredient of the PRS standard with respect to PRS sample. For HPLC-UV, Symmetry C8 (4.6 mm x 100 mm, 5 µm) and for UPLC-PDA, Waters Acquity BEH C8 (2.1 mm x 100 mm, 1.7 µm id) was used for the analysis. The analysis was carried out with 20 mM ammonium formate (3.0 pH with formic acid) and acetonitrile in the composition of (82: 18, v/v) with 0.80 mL/min of flow and (75: 25, v/v) with 0.250 mL/min of flow for HPLC and UPLC, respectively with 276 nm of detection wavelength which shows the ruggedness of the method. The retention time and analysis time of PRS in UPLC are shorter as compared to HPLC. The correlation coefficient of the linearity study was 0.9999 for both instruments. The method is also tested for specificity study of PRS, which shows the method is very simple, rapid and precise with the significance of method transfer. The % RSD values of validation parameters were within the acceptance criteria as per the International Conference of Harmonization (ICH) guidelines. This validated stability indicating method shows the less consumption of solvent, faster analysis and less concentration amount of drug-loaded in a column indicates greener advantages with sensitive detection limit. GRAPHICAL ABSTRACT: UF0001