Fluorescence Detection of Etoposide Encapsulated Mesoporous Silica Nanoparticles by Environmentally Benign Bioanalytical HPLC Method and its Application to Pharmacokinetic Study
Seema Saroj1★, Priya Shah2, Sadhana J. Rajput3★ Corresponding author
- 1Injectables Formulation Development, Alembic Research Centre, Alembic Pharmaceuticals Limited, Gorwa, Vadodara, Gujarat, INDIA.
- 2Injectables R&D Advanced Characterization Laboratory, Alembic Research Centre, Alembic Pharmaceuticals Limited, Gorwa, Vadodara, Gujarat, INDIA.
- 3Department of Pharmaceutical Quality Assurance, Centre for Excellence in NDDS. Faculty of Pharmacy, G.H. Patel Pharmacy Building, The Maharaja Sayajirao University of Baroda, Vadodara, Gujarat, INDIA.
CORRESPONDENCE
Seema Saroj
Research Scientist, Injectables Formulation Development, ARC Alembic Pharmaceuticals Limited, Gorwa, Vadodara-390003, Gujarat, INDIA.
Received: 24-07-2022; Revised: 13-02-2023; Accepted: 20-05-2023.
Volume 57, Issue 3 · pp. 854–863 · PUBLISHED 2023 · DOI: 10.5530/ijper.57.3.103
ABSTRACT
Introduction: Etoposide belongs to BCS Class IV suffering from solubility and permeability limitations. Thereby, hindering its bioavailability. Thereby, it is imperative to enhance its bioavailability by suitable formulation to achieve a desired therapeutic effect. Objectives: In present work, ETD was encapsulated into mesoporous silica nanoparticles (MSNs) with the aim of achieving bioavailability enhancement. Further, A simple, efficient, and environmentally benign HPLC method with highly sensitive fluorescence detection was developed for determination of Etoposide (ETD) in the mice plasma. Materials and Methods: The developed HPLC-FL method was sensitive enough to detect etoposide in the nano formulation in a plasma matrix with a high degree of accuracy and precision, taking Tapentadol as an internal standard. The chromatographic separation was conducted on a Waters symmetry C18 column with a mobile phase composition of methanol:formate buffer (20mM) pH 3.9 in ratio 51:49 at a flow rate of 1 mL/min with excitation wavelength fixed at 247 nm and emission measured at 323 nm. Plasma sample pre-treatment was done following protein precipitation method. The developed bioanalytical method was validated successfully. Green metric assessment was done and Eco-indicators were employed which suggested the Eco-friendliness of developed method as well as supremacy over those available so far. Results: The bioavailability was enhanced 4.35 times as compared to ETO alone. The pharmacokinetic parameters of orally administered MSNs formulation were t1/2 (Half-life) 12.12 hr, Peak plasma concentration Cmax 3.98, Area Under the Curve (AUC) 52.78 and Mean Residence Time 18.23 hr. Conclusion: It could be concluded that the developed mesoporous formulation played a major part in BA enhancement of ETD and the developed green method was highly efficient to serve the purpose of ETD determination from biological matrix.
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Saroj, S., Shah, P., & Rajput, S. J. (2023). Fluorescence Detection of Etoposide Encapsulated Mesoporous Silica Nanoparticles by Environmentally Benign Bioanalytical HPLC Method and its Application to Pharmacokinetic Study. Indian Journal of Pharmaceutical Education and Research, 57(3), 854–863. https://doi.org/10.5530/ijper.57.3.103