Development and validation of an HPLC method for the determination of hyaluronic acid active substance in pharmaceutical formulations
Development and validation of an HPLC method for the determination of hyaluronic acid active substance in pharmaceutical formulations
It is an analytical requirement to identify and determine high molecular weight APIs in pharmaceutical forms. For this reason, it is aimed to develop and validate an analytical method for the determination of hyaluronic acid in pharmaceutical form in this study. 0.1 M Na2SO4 was prepared as mobile phase. The separation of compound was performed with a OHpak Shodex SB-806M HQ (13 μm, 8,0 x 300mm, Japan) analytical column. Guard column which is OHpak SB-G, (8 μm, 100 Å, 6.0 x 50 mm, Japan) was integrated to the system before the analytical column. UV detection at 198 nm was used to monitor the eluent and flow rate of the mobile phase was set to 1 mL/min. The method has been validated in terms of system suitability, linearity, limits of detection (LOD) and quantity (LOQ), precision, accuracy, specificity, selectivity, and stability. The obtained findings showed that the analytical method has linearity higher than 0.99, accuracy, precision, selectivity and stability. The method was found to be precise, accurate and specific during the study.
___
- [1] Sudha PN, Rose MH. Beneficial Effects of Hyaluronic Acid. Adv Food Nutr Res. 2014; 137–176. [CrossRef]
- [2] Gerwin N, Hops C, Lucke A. Intraarticular Drug Delivery in Osteoarthritis. Adv Drug Deliv Rev. 2006; 58: 226–242. [CrossRef]
- [3] Kuo JW, Swarm DA, Prestwich GD. Chemical Modification of Hyaluronic Acid by Carbodiimides. Bioconjug Chem. 1991; 2: 232–241. [CrossRef]
- [4] Ito T, Yeo Y, Highley CB, Bellas E, Benitez CA, Kohane DS. The Prevention of Peritoneal Adhesions by In Situ Cross- Linking Hydrogels of Hyaluronic Acid And Cellulose Derivatives. Biomaterials. 2007; 28: 975–983. [CrossRef]
- [5] Yeo Y, Highley CB, Bellas E, Ito T, Marini R, Langer R, Kohane DS. In Situ Cross-Linkable Hyaluronic Acid Hydrogels Prevent Post-Operative Abdominal Adhesions in A Rabbit Model. Biomaterials. 2006; 27: 4698–4705. [CrossRef]
- [6] Shen H, Shi S, Zhang Z, Gong T, Sun X.. Coating Solid Lipid Nanoparticles with Hyaluronic Acid Enhances Antitumor Activity Against Melanoma Stem-Like Cells. Theranostics. 2015; 5: 755–771. [CrossRef]
- [7] Kašparová J, Arnoldová K, Korecká L, Ceslova L.. Determination of Hyaluronic Acid in Pharmaceutical Products by Spectrophotometry and HPLC Coupled to Fluorescence or Mass Spectrometric Detection. Fac Chem Technol. 2018; 24: 39-47.
- [8] Saari H, Konttinen YT, Friman C, Sorsa T. Differential Effects of Reactive Oxygen Species on Native Synovial Fluid And Purified Human Umbilical Cord Hyaluronate. Inflammation. 1993; 17: 403–415. [CrossRef]
- [9] Ruckmani K, Shaikh SZ, Khalil P, Muneera MS, Thusleem OA. Determination of Sodium Hyaluronate in Pharmaceutical Formulations by HPLC-UV. J Pharm Anal. 2013; 3: 324–329. [CrossRef]
- [10] Trathnigg B. Size-exclusion Chromatography of Polymers. Meyers R., editor. John Wiley & Sons, Ltd; 2000. [CrossRef]
- [11] Ustündağ Okur N, Yavaşoğlu A, Karasulu HY. Preparation and Evaluation of Microemulsion Formulations of Naproxen For Dermal Delivery. Chem Pharm Bull. 2014; 62: 135–143. [CrossRef]
- [12] Üstündağ Okur N, Çağlar EŞ, Pekcan AN, Okur ME, Ayla Ş. Preparation, optimization and in vivo anti-inflammatory evaluation of hydroquinone loaded microemulsion formulations for melasma treatment. J Res Pharm. 2019; 23: 662– 670. [CrossRef]
- [13] Gremião MPD, Cocenza Urban MC, Mainardes RM, et al. Development and Validation of HPLC Method for Analysis of Dexamethasone Acetate in Microemulsions. Brazilian J Pharm Sci. 2009; 45(1): 87-92 [CrossRef] [14] Md Sabir A, Moloy M, Parminder BS. HPLC Method Development and Validatıon: A Review. Int Res J Pharm. 2013; 4: 39–46.[CrossRef]
- [15] Soo Lim H, Young Hwang J, Choi EA, Gunyoung L, Yoon SS, Kim M. Development And Validation of HPLC Method for The Determination of Ferrocyanide Ion in Food Grade Salts. Food Chem. 2018; 239: 1167–1174. [CrossRef]
- [16] Batrawi N, Naseef H, Al-Rimawi F. Development and Validation of a Stability-Indicating HPLC Method for the Simultaneous Determination of Florfenicol and Flunixin Meglumine Combination in an Injectable Solution. J Anal Methods Chem. 2017; 2017: 1529280. [CrossRef]
- [17] Landim LP, Feitoza GS, da Costa JGM. Development and Validation of a HPLC Method for The Quantification of Three Flavonoids in A Crude Extract of Dimorphandra Gardneriana. Brazilian J Pharmacogn. 2013; 23: 58–64. [CrossRef]
- [18] Üstündağ Okur N, Er S, Çağlar EŞ, Ekmen TZ, Sala F. Formulation of Microemulsions for Dermal Delivery of Cephalexin. Acta Pharm Sci. 2017; 55: 27–40. [CrossRef]
- [19] Motohashı N, Morı I. Quantitation of Hyaluronic Acid and Chondroitin Sulphates in Rabbit Synovial Fluid by High- Performanc Liquid Chromatography of Oligosaccharides Enzymatically Derived Thereof. Chem Pharm Bull. 1990; 38: 769–773. [CrossRef]
- [20] ICH Expert Working Group. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH harmonised tripartite guideline validatiın of analytical procedures: text and methodology Q2(R1) [Internet]. Fed. Regist. Vol. 62, No. 96. 1997 [cited 2020 Dec 10]. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__G uideline.pdf.
- [21] Urban MCC, Mainardes RM, Gremião MPD. Development and Validation of HPLC Method For Analysis of Dexamethasone Acetate in Microemulsions. Brazilian J Pharm Sci. 2009 ; 45: 87–92. [CrossRef]
- [22] Food and Drug Administration. Analytical Procedures and Methods Validation for Drugs and Biologics [Internet]. Guid. Ind. 2015 [cited 2020 Nov 24]. Available from: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.