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

Research Article Volume 6 Issue 8

A Novel Bioanalytical LC/MS/MS Assay for the Determination of Procyclidine in Human Plasma and its Pharmacokinetics Applications

Mohamed Raslan1, Eslam MS1, Sara AR1 and Nagwa A Sabri2*

1Drug Research Centre, Cairo, Egypt.
2Department of Clinical Pharmacy, Faculty of Pharmacy- Ain Shams University, Cairo, Egypt

*Corresponding Author: Nagwa A Sabri, Department of Clinical Pharmacy, Faculty of Pharmacy- Ain Shams University, Cairo, Egypt.

Received: June 07, 2022; Published: July 29, 2022

Abstract

Background: Parkinson's disease (PD) is a prevalent chronic degenerative nervous system disorder. Procyclidine is a medication used improve to motor functions.

Aim: Development of a bio-analytical procedure for rapid quantitative estimation of procyclidine in human plasma and its application in pharmacokinetics, bioavailability studies, and therapeutic drug monitoring to aid in the achievement of effective clinical results in Parkinson's disease management.

Methods: Sample clean-up was performed to extract procyclidine from plasma samples using liquid-lquid extraction technique. Chromatography was performed using 4mM Ammonium Acetate : Methanol 25 : 75 V/V. The pump flow rate was setted at 0.7 ml/min. ESI was setted at positive mode, and m/z 288.2 à 84, 302.2 à 98.1 for procyclidine and trihexyphenidyl as internal standard respectively. A comparative bioavailability study of procyclidine 5mg tablets generic product versus reference product was done in a crossover design with 24 subjects as an application of the validated bioanalytical methodology. The pharmacokinetic parameters used to evaluate the two products bioequivalence were Cmax, AUC 0-t, AUC 0-inf, and Tmax.

Results: The average procyclidine recovery was 91.118%. The quantitation limit was 0.1 ng/ml, and the correlation coefficient (r2) was 0.9998. Furthermore, statistical analysis of the results obtained revealed no significant difference between the two products.

Conclusion: The established bioanalytical LC/MS/MS method was successfully applied for procyclidine quantification in human plasma. Furthermore, it is appropriate for use in pharmacokinetic studies and therapeutic drug monitoring in parkinson's disease management. This can ensure clinically effective drug levels in human plasma and avoid possible unwanted adverse outcomes.

Keywords: Procyclidine; Parkinson’s Disease; LC/MS/MS; Validation; Liquid-liquid Extraction

References

  1. Procyclidine hydrochloride - FDA.
  2. Deutch AY and Roth RH. “Neurotransmitters”. In: Zigmond MJ, Bloom FE, Landis SC, Roberts JL, Squire LR (eds). Fundamental Neuroscience. Academic Press: San Diego (1999): 193-234.
  3. Waxham MN. “Neurotransmitter receptors”. In: Zigmond MJ, Bloom FE, Landis SC, Roberts JL, Squire LR (eds). Fundamental Neuroscience. Academic Press: San Diego (1999): 235-267.
  4. Whiteman PD., et al. “Pharmacokinetics and Pharmacodynamics of procyclidine in man”. European Journal of Clinical Pharmacology1 (1985): 73-78.
  5. Dean K., et al. “Analysis of procyclidine in human plasma and urine by gas-liquid chromatography”. Journal of Chromatography 2 (1980): 408-413.
  6. A Rudolphi and KS Boos. LC GC 15 (1997) 814.
  7. R Oertel., et al. Journal of Chromatography A 797 (1998): 203.
  8. EA Hogendoorn., et al. Analytical Chemistry 70 (1998): 1362.
  9. Z Yu and D Westerlund. Journal of Chromatography A 725 (1996): 149.
  10. “Bioavailability Studies Submitted in NDAs or INDs - General Considerations” (2019).
  11. Guidance for Industry Bioanalytical Method Validation (2013).
  12. “Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study” (2013).
  13. Nagwa A Sabri., et al. “Quantification of Cyclobenzaprine in Human Plasma by LC/MS/MS and its Pharmacokinetics Application". Acta Scientific Pharmaceutical Sciences11 (2020): 90-96.
  14. R Sara., et al. “Hydroxychloroquine and Management of COVID-19 What is behind its Accurate Detection in its Pharmaceutical Products?”. Saudi Journal of Medical and Pharmaceutical Sciences 6 (2020): 644-653.
  15. Zahraa Hassan Abdelrahman Shehata., et al. “Descriptive analysis of medication errors reported to the Egyptian national online reporting system during six months”. Journal of the American Medical Informatics Association 2 (2016): 366-374.
  16. Fink M., et al. “Clinical efficacy of chlorpromazine-procyclidine combination, imipramine and placebo in depressive disorders”. Psychopharmacologia 7 27-36 (1965).
  17. Termsarasab P., et al. “Medical treatment of dystonia”. Journal of Clinical Movement Disorders 3 (2016): 19.
  18. Kumari V., et al. “Effects of procyclidine on prepulse inhibition of the acoustic startle response in healthy human volunteers”. Psychopharmacology (Berl)3 (2001): 221-229.

Citation

Citation: Nagwa A Sabri., et al. “Forced Degradation Studies for Estimation of Finerenone by RP-HPLC Method". Acta Scientific Pharmaceutical Sciences 6.8 (2022): 25-32.

Copyright

Copyright: © 2022 Nagwa A Sabri., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.
  • Submission Timeline for Upcoming Issue
    The last date for submission of articles for regular Issues is October 10, 2022.
  • Publication Certificate
    Authors will be issued a "Publication Certificate" as a mark of appreciation for publishing their work.
  • Best Article of the Issue
    The Editors will elect one Best Article after each issue release. The authors of this article will be provided with a certificate of “Best Article of the Issue”.
  • Welcoming Article Submission
    Acta Scientific delightfully welcomes active researchers for submission of articles towards the upcoming issue of respective journals.
  • Contact US