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 C_max, AUC _0-t, AUC _0-inf, and T_max.

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

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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.