High Performance Liquid Chromatography-Size Exclusion Chromatography (Hplc-Sec) As an Efficient Tool for The Quantification of Polymers
Keywords:Poly (Lactide-Co-Glycolide Acid, PLGA, Quantification, HPLC-SEC, Refractive Index
Poly (lactide-co-glycolide acid) ( PLGA) is an extraordinary well-described polymer and has excellent pharmaceutical properties like high biocompatibility and good biodegradability. Hence, it is one of the most used materials for drug delivery and biomedical systems, also being present in several US Food and Drug Administration approved carrier systems and therapeutic devices. For both applications, the quantification of polymer is important. During the development of the production process, parameters like yield or loading efficacy are essential to be determined. Although PLGA is a well-defined biomaterial, it still lacks a sensitive and convenient quantification approach for PLGA-based systems. Thus, we present a new method for fast and precise quantification of PLGA by HPLC-SEC. The method includes a shorter run time of 20 minutes with a size exclusion column of 300mm x 8.0mm diameter, tetrahydrofuran as mobile phase and diluent, the detection was carried out using the refractive index detector. The developed method has a detection limit of 0.1 ppm, enabling the quantification of low amounts of PLGA. Compared to existing approaches, like gravimetric or nuclear magnetic resonance measurements, which are tedious or expensive, the developed method is fast, ideal for routine screening and it is selective since no interference. The developed method is validated in terms of selectivity, precision, linearity, accuracy and solution stability. Due to the high sensitivity and rapidity of the method, it is suitable for both, laboratory and industrial use
J. P. Kitchell, D. L. Wise, Poly (lactic/glycolic acid) biodegradable drug-polymer matrix systems, Meth.Enzymol.112(1985)436-448.
L. Brannon-Peppas, Recent advances on the use of biodegradable microparticles and nanoparticles in controlled drug delivery, Int J Pharm.116(1995)1-9.
H. Sah, Overview of Polylactide-co-Glycolide Drug delivery systems, in: M. N. V. R. Kumar (Ed.), Handbook of Polyester Drug Delivery Systems, Pan Standford, NewYork, USA,2016, pp.159-185.
J. Yang, Y. Zeng, Y. Li, et al., Intravascular site-specific delivery of therapeutic antisense for the inhibition of restenosis, Eur J Pharm Sci.35 (2008) 427-437.
C. Martins, F. Sousa, F. Araujo, et al., Functionalizing PLGA and PLGA Derivatives for Drug Delivery and Tissue Regeneration Applications, Adv Healthcare Mater.7 (2018)1701035.
N. Bahari Javan, H. Montazeri, L. resale Shirmard, et al., Preparation, characterization and in vivo evaluation of a combination delivery system based on hyaluronic acid/jeffamine hydrogel loaded with PHBV/PLGA blend nanoparticles for prolonged delivery of Teriparatide, Eur J Pharm Sci.101 (2017)167-181.
M.M. Ayoub, N.G. Elantouny, H.M. EI-Nahas, et al., Injectable PLGA Adefovir microspheres; the way for long term therapy of chronic hepatitis-B, Eur J Pharm Sci.118 (2018) 24-31.
S. Jose, S.Sowmya, T. A. Cine, et al., Surface modified PLGA nanoparticles for brain targeting of Bacoside-A, Eur J Pharm Sci.63 (2014) 29-35.
D. Primavessy, N. Gunday Tureli, M. Schneider, the influence of different stabilizers on the encapsulation of desmopressin acetate into PLGA nanoparticles, Eur J Pharm Biopharm.118 (2017) 48-55.
C. Shi, C. Thum, Q. Zhang, et al., Inhibition of cancer associated TASK 3 Channels by the magnetically induced thermal release of Tetrandrine from a polymeric drug carrier, J Control Release.237 (2016) 50-60.
H. K. Makadia, S. J. Siegel, Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier, Polymers (Basel).3 (2011) 1377-1397.
S. Fredenberg, M. Wahlgren, M. Reslow, et al., The mechanisms of drug release in Poly (lactic-co-glycolic acid) based drug delivery systems-A review, Int J Pharm.415 (2011) 34-52.
M.Hauser, K. Langer, M. Schonhoff, pH-Triggered release from surface modified Poly (lactic-co-glycolic acid) nanoparticles, Beilstein J Nanotechnol.6 (2015) 2504-2512.
N. Gunday Tureli, A. Torge, J. Juntke, et al., Ciprofloxacin-loaded PLGA nanoparticles against cystic fibrosis P. aeruginosa lung infections, Eur J Pharm biopharm. 117 (2017) 363-371.
A. Ghaffar, P. G. verschuren, J. A. J. Greenvasen, et al., Fast in vitro hydraulic degradation of polyester urethane acrylate biomaterials: structure elucidation, separation and quantification of degradation products, J Chromatogr A.1218(2011) 449-458.
Q. Zhang, N. Guo, Y. Sun, et al., Absolute quantification of poly(dl-lactide-co-glycolide) in microspheres using quantitative 1H NMR spectroscopy, J Pharm Biomed Anal. 146 (2017) 273-278.
N. Ibrisimovic, H. Al-Dubai, V. Kerleta, et al., Quantification of biodegradable PLGA nanoparticles for drug targeting, Ama.39 (2010) 118-131.