Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 4 Issue 5

Development and Validation of First Order Derivative Spectrophotometric Methods for the Assay of Prucalopride Succinate

Goutham Dev Ashish Bojja and Mukthinuthalapati Mathrusri Annapurna*

Gandhi Institute of Technology and Management (Deemed to be) University, GITAM Institute of Pharmacy, Visakhapatnam, India

*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, GITAM Institute of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam, India.

Received: April 13, 2020; Published: May 04, 2019



  Prucalopride succinate is an orally active and selective, high affinity 5-HT4 receptor agonist which targets the impaired motility associated with chronic constipation and thus normalizing bowel movements. It is used for the treatment of chronic constipation. Four new first order derivative spectrophotometric methods have been developed for the assay of Prucalopride succinate in pharmaceutical formulations. Prucalopride succinate was estimated using reagents such as 0.1N HCl (Method A), phosphate buffer (pH 2.0) (Method B), acetate buffer (pH 5.0) (Method C) and 0.1N NaOH (Method D). Beer-Lambert’s law was obeyed over the concentration range 5 - 60 μg/ml in Method A and B and 5 - 50 μg/ml in Method C and D. The methods were found to be simple, precise, accurate, economical and the methods were validated as per ICH guidelines. These methods can be successfully applied for the determination of Ketorolac tromethamine in pharmaceutical dosage forms.

Keywords:First Derivative Spectroscopy; Prucalopride Succinate; Spectroscopy; Phosphate Buffer; Acetate Buffer; Sodium Hydroxide; HCl; Validation



  1. Leclere PG., et al. “5-HT4 receptors located on cholinergic nerves in human colon circular muscle”. Neurogastroenterology and Motility 3 (2005): 366-375.
  2. Joslyn A., et al. “Prucalopride is safe and generally well tolerated in elderly patients with chronic constipation”. American Journal of Gastroenterology9 (2000): 2537-2538.
  3. De Schryver AM., et al. “The effects of the specific 5HT(4) receptor agonist, prucalopride, on colonic motility in healthy volunteers”. Alimentary Pharmacology and Therapeutics 3 (2002): 603-612.
  4. Emmanuel AV., et al. “Effect of a novel prokinetic drug RO93877 on gastrointestinal transit in healthy volunteers”. Gut4 (1998): 511-516.
  5. Bouras EP., et al. “Selective stimulation of colonic transit by the benzofuran 5-HT4 agonist, Prucalopride in healthy humans”. Gut 5 (1999): 482-486.
  6. Bouras EP., et al. “Prucalopride accelerates gastrointestinal and colonic transit in patients with constipation”. Gastroenterology 2 (2001): 354-360.
  7. Sun Z., et al. “Development and validation of a sensitive UHPLC-MS/MS method for quantitation of Prucalopride in rat plasma and its application to pharmacokinetics study”. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences 1033-1034 (2016): 328-333.
  8. Mahamuni BS., et al. “Selective separation and characterisation of stress degradation products and process impurities of Prucalopride succinate by LC-QTOF-MS/MS”. Journal of Pharmaceutical and Biomedical Analysis 125 (2016): 219-228.
  9. Virag Gophane and Ravi AT. “Development, validation and stability indicating rp-hplc method for estimation of Prucalopride in pharmaceutical formulation”. Inventi Rapid: Pharm Analysis and Quality Assurance 3 (2016): 1-8.
  10. Buiter HJ., et al. “Radiosynthesis and preclinical evaluation of [11C] Prucalopride as a potential agonist PET ligand for the 5-HT4 receptor”. EJNMMI Research1 (2013): 24.
  11. ICH Q2 [R1] validation of analytical procedures: Text and Methodology: November 2005.


Citation: Goutham Dev Ashish Bojja and Mukthinuthalapati Mathrusri Annapurna. “Development and Validation of First Order Derivative Spectrophotometric Methods for the Assay of Prucalopride Succinate". Acta Scientific Pharmaceutical Sciences 4.5 (2020): 78-82.


Acceptance rate32%
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