Mandour, H., Belal, T., Ramadan, A., Sharabi, F., Shamseddeen, M. (2024). Qualitative and quantitative analysis of some tramadol registered and illegitimate dosage forms in Egypt. test, 1(1), 11-21. doi: 10.21608/japs.2024.255337.1011
Hebat-ALLAH I. Mandour; Tarek S. Belal; Alyaa A. Ramadan; Fouad M. Sharabi; Mohamed A. Shamseddeen. "Qualitative and quantitative analysis of some tramadol registered and illegitimate dosage forms in Egypt". test, 1, 1, 2024, 11-21. doi: 10.21608/japs.2024.255337.1011
Mandour, H., Belal, T., Ramadan, A., Sharabi, F., Shamseddeen, M. (2024). 'Qualitative and quantitative analysis of some tramadol registered and illegitimate dosage forms in Egypt', test, 1(1), pp. 11-21. doi: 10.21608/japs.2024.255337.1011
Mandour, H., Belal, T., Ramadan, A., Sharabi, F., Shamseddeen, M. Qualitative and quantitative analysis of some tramadol registered and illegitimate dosage forms in Egypt. test, 2024; 1(1): 11-21. doi: 10.21608/japs.2024.255337.1011

Qualitative and quantitative analysis of some tramadol registered and illegitimate dosage forms in Egypt

Journal of Advanced Pharmaceutical Sciences
Volume 1, Issue 1, January 2024, Pages 11-21    PDF (510.13 K)
Document Type: Original Article
DOI: 10.21608/japs.2024.255337.1011
Authors
Hebat-ALLAH I. Mandour* 1; Tarek S. Belal2; Alyaa A. Ramadan3; Fouad M. Sharabi4; Mohamed A. Shamseddeen3
1Department of Clinical Pharmacy and Pharmacy Practice, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt
2Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt
3Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt
4Department of Pharmacology and Toxicology, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt
Abstract
Despite tramadol is a strong pain relief authorized medication, it is currently considered among the highly abused substances in Egypt. Due to consequent strict legal acts on the registered brands of tramadol, available illegitimate products were widely distributed on the streets in Egypt. The claim of many patients receiving treatment while suffering from seizures together with the assumption of inferior authenticity of these products, led the initiative to work on the qualitative and quantitative analysis of such products while comparing their content to the registered brands in the Egyptian market. Results obtained by applying a validated HPLC-DAD method as a highly efficient technique in pharmaceutical analysis revealed that most of the content of these products was within the limit of the labelled claim, with the exception of one compound that showed an additional different peak. Efforts to identify such a peak through analysis and comparison of the spectrum referred it to paracetamol, the well-known analgesic commonly combined with tramadol in its dosage forms. The employed HPLC procedure involved the use of a RP-C18 column, mobile phase of phosphate buffer (pH 6.0) and methanol (40:60, v/v) and diode array detection at 220 and 270 nm. Accurate, precise, and reliable testing procedures under governmental surveillance are required to assure the persistent quality and safety of the available drugs on the market.

Highlights
  • An HPLC-DAD adopted method was successful for the analysis of Tramadol-registered and illegitimate dosage forms in Egypt.
  • Most analyzed tramadol illegitimate dosage forms showed acceptable content recovery.
  • Only one extra peak for co-formulated paracetamol in a single tramadol illegitimate dosage form was identified within the selected detection wavelength.
  • Seizures occur with tramadol use in doses higher than therapeutically recommended and not as assumed due to other concomitantly added adulterants.
  • Pharmacists play an integral part in the surveillance of illegitimate dosage forms to protect society.
Keywords
Tramadol use; illegitimate products; counterfeit; HPLC
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