Development and validation of an HPLC method for determination of quercetin

Abstract

Abstract This study validated a high performance liquid chromatography (HPLC) method for the determination of quercetin (QE) in microemulsion (ME) based gel formulations. The analyses were performed on a C18 column (150x4.6 mm, 5 m particle size) at room temperature with UV detection at 254 nm. The mobile phase was composed of methanol:water (65:35, v/v, 2% acetic acid) mixture, and flow rate was set to 1 mL/min. The method was validated according to the international guidelines with respect to linearity range, stability, limit of quantitation and detection, precision and accuracy. The method was linear within 5 – 100 µg/mL range with a correlation coefficient of 0.9995. The intra- and inter-assay precisions presented RSD values lower than 2%. The method reported is a fast and reliable HPLC method useful for QE determination in ME based gel formulations.

Keywords

• Quercetin
• microemulsion based gel
• validation
• HPLC

References

1. [1] Davis JM, Murphy EA, Carmichael MD. Effects of the dietary flavonoid quercetin upon performance and health. Curr. Sports Med. Rep. (2009); 8, 206-213. https://doi.org/10.1249/JSR.0b013e3181ae8959
2. [2] Aguirre LAN, Macarulla MT, Gracia A, Portillo MP. Beneficial effects of quercetin on obesity and diabetes. Open Nutraceuticals Journal. (2011); 4(1), 89-198.
3. [3] Fasolo D, Bassani VL, Teixeira HF, Development of topical nanoemulsions containing quercetin and 3-O-methylquercetin. Die Pharmazie-An International Journal of Pharmaceutical Sciences. (2009); 64(11), 726-730. https://doi.org/10.1691/ph.2009.8357
4. [4] Chessa M, Caddeo C, Valenti D, Manconi M, Sinico C, Fadda AM. Effect of Penetration Enhancer Containing Vesicles on the Percutaneous Delivery of Quercetin through New Born Pig Skin. Pharmaceutics. (2011); 3(3), 497-509. https://doi.org/10.3390/pharmaceutics3030497
5. [5] Scalia S, Franceschinis E, Bertelli D, Iannuccelli V. Comparative evaluation of the effect of permeation enhancers, lipid nanoparticles and colloidal silica on in vivo human skin penetration of quercetin. Skin Pharmacology And Physiology. (2013); 26(2), 57-67. https://doi.org/10.1159/000345210
6. [6] Bose S, Du Y, Takhistov P, Michniak-Kohn B. Formulation optimization and topical delivery of quercetin from solid lipid based nanosystems. International Journal of Pharmaceutics. (2013); 441(1-2), 56-66. https://doi.org/10.1016/j.ijpharm.2012.12.013
7. [7] Bose S, Michniak-Kohn B. Preparation and characterization of lipid based nanosystems for topical delivery of quercetin. European Journal of Pharmaceutical Sciences. (2013); 48(3), 442-452. https://doi.org/10.1016/j.ejps.2012.12.005
8. [8] Rothwell JA, Day AJ, Morgan MR. Experimental determination of octanol-water partition coefficients of quercetin and related flavonoids. Journal Of Agricultural And Food Chemistry. (2005); 53(11), 4355-4360. https://doi.org/10.1021/jf0483669

9. [9] Kajbafvala A, Salabat A, Salimi A. Formulation, characterization, and in vitro/ex vivo evaluation of quercetin-loaded microemulsion for topical application. Pharmaceutical Development And Technology. (2018); 23(8), 741-750. https://doi.org/10.1080/10837450.2016.1263995
10. [10] Yang C, Shen Y, Wang J, Ouahab A, Zhang, Tu J. Cationic polymer-based micro-emulgel with self-preserving ability for transdermal delivery of diclofenac sodium. Drug Delivery. (2015); 22(6), 814-822. https://doi.org/10.3109/10717544.2014.898111
11. [11] Ashara KC, Paun, JS, Soniwala M M, Chavda JR, Mendapara VP, Mori NM. Microemulgel: An overwhelming approach to improve therapeutic action of drug moiety. Saudi Pharmaceutical Journal. (2016); 24(4), 452-457. http://dx.doi.org/10.1016/j.jsps.2014.08.002
12. [12] Shinde UA, Modani S H, Singh KH. Design and development of repaglinide microemulsion gel for transdermal delivery. AAPS PharmSciTech, (2018); 19(1), 315-325.
13. [13] Wan T, Xu T, Pan J, Qin M, Pan W, Zhang G, Xu Y. Microemulsion based gel for topical dermal delivery of pseudolaric acid B: in vitro and in vivo evaluation. International Journal Of Pharmaceutics. (2015); 493(1-2), 111-120. https://doi.org/10.1016/j.ijpharm.2015.07.058
14. [14] Araujo GRS, de Oliveira Porfírio L, Silva LAS, Santana DG, Barbosa PF, Dos Santos CP, Lira AAM. In situ microemulsion-gel obtained from bioadhesive hydroxypropyl methylcellulose films for transdermal administration of zidovudine. Colloids and Surfaces B: Biointerfaces. (2020); 188, 110739. https://doi.org/10.1016/j.colsurfb.2019.110739
15. [15] Pandey SS, Maulvi FA, Patel PS, Shukla MR, Shah KM, Gupta AR, Shah DO. (2020). Cyclosporine laden tailored microemulsion-gel depot for effective treatment of psoriasis: in vitro and in vivo studies. Colloids and Surfaces B: Biointerfaces. (2020); 186, 110681. https://doi.org/10.1016/j.colsurfb.2019.110681
16. [16] Kuntić V, Pejić N, Mićić S, Vukojević V, Vujić Z, Malešev D. Determination of quercetin in pharmaceutical formulations via its reaction with potassium-titanyloxalate: Determination of the stability constants of the quercetin-titanyloxalato complex. Journal of the Serbian Chemical Society. (2005); 70(5), 753-763.
17. [17] Mythili T, Ravindhran R. Determination of Quercetin by HPTLC Method in SesbaniaSesban (L.) Merr. Stem Extract. International Journal of Advences in Pharmacy, Biology and Chemistry. (2013); 2(1), 113-119.
18. [18] Pejic N, Kuntic V, Vujic Z, Micic S. Direct spectrophotometric determination of quercetin in the presence of ascorbic acid. Il Farmaco. (20024); 59(1), 21-24. https://doi.org/10.1016/j.farmac.2003.07.013
19. [19] Casagrande R, Baracat MM, Georgetti SR, Verri Jr WA, Vicentini FT, Rafael JA, Fonseca M J. (2009). Method validation and stability study of quercetin in topical emulsions. Química Nova. (2009); 32 (7), 1939-1942. https://doi.org/10.1590/S0100-40422009000700041
20. [20] ICH Harmonised Tripartite Guideline. Validation of analytical procedures: text and methodology Q2 (R1). In International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. (2005, October) Switzerland: Geneva.
21. [21] Gao L, Liu G, Wang X, Liu F, Xu Y, Ma J. Preparation of a chemically stable quercetin formulation using nanosuspension technology, International Journal of Pharmaceutics. (2011); 404, 231–237. https://doi.org/10.1016/j.ijpharm.2010.11.009
22. [22] Hatahet T, Morille M, Hommoss A, Dorandeu C, Muller RH, Begu S. Dermal quercetin smartCrystals(R): formulation development, antioxidant activity and cellular safety. European Journal Of Pharmaceutics And Biopharmaceutics. (2016); 102, 51-63. https://doi.org/10.1016/j.ejpb.2016.03.004
23. [23] Nikumbh KV, Sevankar SG, Patil MP. Formulation development, in vitro and in vivo evaluation of microemulsion-based gel loaded with ketoprofen. Drug Delivery. (2015); 22(4), 509-515. https://doi.org/10.3109/10717544.2013.859186
24. [24] Merisko-Liversidge E, Liversidge GG, Cooper ER. Nanosizing: a formulation approach for poorly-water-soluble compounds. European Journal of Pharmaceutical Sciences. (2003); 18, 113-120. https://doi.org/10.1016/S0928-0987(02)00251-8