Get 20M+ Full-Text Papers For Less Than $1.50/day. Start a 14-Day Trial for You or Your Team.

Learn More →

A Validated Stability-Indicating Method for Separation of Prucalopride Drug by HPLC: Method Transfer to UPLC

A Validated Stability-Indicating Method for Separation of Prucalopride Drug by HPLC: Method... 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

A Validated Stability-Indicating Method for Separation of Prucalopride Drug by HPLC: Method Transfer to UPLC

Download PDF

A Validated Stability-Indicating Method for Separation of Prucalopride Drug by HPLC: Method Transfer to UPLC

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...
Loading next page...
 
/lp/taylor-francis/a-validated-stability-indicating-method-for-separation-of-prucalopride-BOd2Sgadnc
Publisher
Taylor & Francis
Copyright
© 2021 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2021.1911680
Publisher site
See Article on Publisher Site

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.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Jul 4, 2021

Keywords: Validation; Significance of Method transfer; Sensitive detection limit; Stability indicating method

References

  • Epidemiology of constipation in North America: a systematic review
  • Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features
  • Prevalence rates for constipation and faecal and urinary incontinence
  • The treatment of chronic constipation in elderly people: an update
  • The health-related quality of life and economic burden of constipation
  • Chronic constipation: a survey of the patient perspective
  • Health-related quality of life in functional GI disorders: focus on constipation and resource utilization
  • Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation - follow-up of patients from the pivotal studies
  • Prucalopride
  • Effect of prucalopride on symptoms of chronic constipation
  • Prucalopride: evaluation of the pharmacokinetics, pharmaco-dynamics, efficacy and safety in the treatment of chronic constipation
  • The efficacy and safety of prucalopride in patients with chronic constipation
  • Clinical trial: the efficacy, impact on quality of life, and safety and tolerability of prucalopride in severe chronic constipation--a 12-week, randomized, double-blind, placebo-controlled study
  • Prucalopride for the treatment of women with chronic constipation in whom standard laxative regimens have failed to provide adequate relief
  • The action of the novel gastrointestinal prokinetic prucalopride on the HERG K+ channel and the common T897 polymorph
  • The in vitro pharmacological profile of prucalopride, a novel enterokinetic compound
  • Development, Validation and Stability Indicating RP-HPLC Method for Estimation of Prucalopride in Pharmaceutical Formulation. Inventi Rapid: Pharm
  • Effect of prucalopride on the pharmacokinetics of oral contraceptives in healthy women
  • Development and validation of a sensitive UHPLC-MS/MS method for quantitation of prucalopride in rat plasma and its application to pharmacokinetics study
  • Pharmacokinetics and tissue distribution study of prucalopride in rats by ultra high performance liquid chromatography with tandem mass spectrometry
  • Selective separation and characterisation of stress degradation products and process impurities of prucalopride succinate by LC-QTOF-MS/MS
  • Stability testing of new drug substances and products (revision 2)
  • Validation of analytical procedure and methodology
  • Selected HPLC Applications - Quick Separation Guide: A Review
  • A Review on Ultra Performance Liquid Chromatography
  • Ultra performance liquid chromatography: an introduction and review