Quality control of the active Pharmaceutical ingredients of some Pharmaceutical products prior the termination of their shelf life
Sakkal Elias, Bitar Yaser, Trefi Saleh*
Quality Control and Pharmaceutical Chemistry Department, University of Aleppo-Syrian Arab Republic
*Corresponding Author E-mail: firstname.lastname@example.org
Online published on 24 February, 2020.
The aim of this study was to assure whether the pharmaceutical products especially those with high risk of degradation are able to maintain their effectiveness before the end of their shelf life in brief period (last 3 months) by comparing them with working standards.
Five compendial HPLC methods depending on USP and European Pharmacopoeia1, 2 were used to analyze five pharmaceutical products (Aspirin, Captopril, Furosemide, Omeprazole and Ranitidine). These pharmaceutical products were kept on the shelf under appropriate storage conditions (Temperature between 15–35Co).
The percentages of the active ingredient remaining during the last 3 months of these pharmaceutical products ranged between: Aspirin (91.17%-97.26%), Captopril (92.52%-99.44%), Furosemide (91.45%-97.23%), Omeprazole (102.35% 103.24%) and ranitidine (95.09%-98.68%). All these percentages were within the acceptance criteria of the USP pharmacopoeia.
The results presented in this paper showed that the active ingredient content of the studied pharmaceutical products decreases slightly over time, however that decrease obtained is not enough to make the active ingredient ineffective, therefore it remains effective during the last 3 months of its shelf life kept in an appropriate storage conditions.
Stability, Shelf life, Aspirin, Captopril, Furosemide, Omeprazole, Ranitidine.