A novel ultrasensitive derivatization-free synchronous fluorescence approach for the simultaneous analysis of propofol and nalbuphine in human plasma and dosage forms: Compliance with greenness and blueness metrics.

Journal: Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy
Published Date:

Abstract

This study presents a very sensitive and eco-friendly synchronous spectrofluorimetric method for the simultaneous quantification of propofol (PRP) and nalbuphine (NAL) for the first time. The technique used the intrinsic fluorescence characteristics of the two drugs, providing enhanced sensitivity and specificity. The two drugs were assessed simultaneously at 217 nm and 281 nm for PRP and NAL, respectively, with a synchronous wavelength difference (Δλ) of 80 nm. The proposed method was validated according to ICH Q2 (R2) requirements, exhibiting satisfactory accuracy, precision, linearity, and selectivity within the designated concentration ranges. The concentrations exhibited linearity within the ranges of 15.0-300.0 ng/mL and 0.5-16.0 µg/mL, with detection limits of 2.67 ng/mL and 0.15 µg/mL for PRP and NAL, respectively. The developed approach, owing to its great sensitivity, was utilized to assess the examined drugs in human plasma samples. The results demonstrated good bioanalytical applicability, exhibiting high recovery percentages (98.40-101.70) and low relative standard deviation (%RSD) values (<1.66). The proposed method was applied to accurately analyze the cited drugs in their ampoule dosage forms with great selectivity. The MoGAPI and AGREE metricsdemonstrated the method's exceptional eco-friendliness and sustainability. Additionally, the BAGI tool was employed to assess the method's economic viability, applicability, and practicality. The three tools demonstrated the sustainability and feasibility of the developedapproach, as well as its appropriateness for the routine analysis of the examined drugs. The developed method represents the first analytical technique for the concurrent estimation of PRP and NAL without the necessity for toxic reagents, excessive organic solvents, or complicated instruments. The method is derivatization-free and does not require complicated sample treatment or lengthy extraction procedures. The suggested method's excellent sensitivity, simplicity, speed, environmental friendliness, and cost-effectiveness make it appropriate for therapeutic drug monitoring of the studied drugs.

Authors

  • Mohamed A El Hamd
    Department of Pharmaceutical Chemistry, College of Pharmacy, Shaqra University, Shaqra 11961, Saudi Arabia; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, South Valley University, Qena 83523, Egypt. Electronic address: aboelhamdmohamed@su.edu.sa.
  • Galal Magdy
    Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Kafrelsheikh University, Kafrelsheikh 33511, Egypt. Electronic address: galal_magdy@pharm.kfs.edu.eg.
  • Mahmoud El-Maghrabey
    Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt. Electronic address: dr_m_hamed@mans.edu.eg.
  • Fotouh R Mansour
    Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Tanta University, Tanta 31111, Egypt; Department of Medicinal Chemistry, Faculty of Pharmacy, King Salman International University (KSIU), South Sinai, Egypt.
  • Lateefa A Al-Khateeb
    Department of Chemistry, Faculty of Science, King Abdulaziz University, P.O. Box 80203, Jeddah 21589, Saudi Arabia.
  • Wael A Mahdi
    Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia.
  • Sultan Alshehri
    Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia.
  • Bandar R Alsehli
    Department of Chemistry, Faculty of Science, Taibah University, Al-Madinah, Al-Munawarah 30002, Saudi Arabia.
  • Aya Saad Radwan
    Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Horus University-Egypt, New Damietta, Egypt. Electronic address: ayasradwan93@gmail.com.

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