Analytical Method Validation and Determination of Free Drug Content of 4-n-Butylresorcinol in Complex Lipid Nanoparticles Using RP-HPLC Method

https://doi.org/10.22146/ijc.28919

Rini Dwiastuti(1), Marchaban Marchaban(2), Enade Perdana Istyastono(3), Florentinus Dika Octa Riswanto(4*)

(1) Faculty of Pharmacy, Universitas Sanata Dharma, Campus 3 Paingan, Maguwoharjo, Depok, Sleman, Yogyakarta 55282, Indonesia
(2) Faculty of Pharmacy, Universitas Gadjah Mada, Yogyakarta 55281, Indonesia
(3) Faculty of Pharmacy, Universitas Sanata Dharma, Campus 3 Paingan, Maguwoharjo, Depok, Sleman, Yogyakarta 55282, Indonesia
(4) Faculty of Pharmacy, Universitas Sanata Dharma, Campus 3 Paingan, Maguwoharjo, Depok, Sleman, Yogyakarta 55282, Indonesia
(*) Corresponding Author

Abstract


Lipid nanoparticles, one of nanoparticle technology results has been developed both as a drug delivery system and as a research object. Complex lipid nanoparticle, in the drug delivery system development, has an advantage due to its less toxicity. It is important to develop a validated analytical method to determine the drug content in the system of nanoparticle lipid. This research aimed to develop a valid RP-HPLC method to determine free drug content of 4-n-butylresorcinol in the liposome matrix followed by the determination of the encapsulation efficiency (EE%). A system of the RP-HPLC method has been developed using a column of C18 and methanol-redistilled water-glacial acetic acid 79:20:1 (v/v) as the mobile phase with pH maintained at 2.1–2.6. This method was validated in the parameters of selectivity, sensitivity, linearity, accuracy, and precision. During 30 days of storage, the complex lipid nanoparticle system showed the increase in the EE% value during storage time.

Keywords


4-n-butylresorcinol; encapsulation efficiency; lipid nanoparticle; validation

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References

[1] Buzea, C., Pacheco I.I., and Robbie, K., 2007, Nanomaterials and nanoparticles: sources and toxicity nanomaterials and nanoparticles: Sources and toxicity, Biointerphases, 2(4), MR17–MR71.

[2] Martien, R., Adhyatmika, Irianto, I.D.K., Farida, V., and Sari, D.P., 2012, Perkembangan teknologi nanopartikel sebagai sistem penghantaran obat, Majalah Farmaseutik, 8 (1), 133–144.

[3] Potocnik, J., 2011, Commission recommendation of 18 October 2011 on the definition of nanomaterial, Off. J. Eur. Union, L275, 38–40.

[4] Reverchon, E., and Adami, R., 2006, Nanomaterials and supercritical fluids, J. Supercrit. Fluids, 37 (1), 1–22.

[5] Puri, A., Loomis, K., Smith, B., Lee, J.H., Yavlovich, A., Heldman, E., and Blumenthal, R., 2009, Lipid-based nanoparticles as pharmaceutical drug carriers: From concepts to clinic, Crit. Rev. Ther. Drug Carrier Syst., 26 (6), 523–580.

[6] Attama, A.A., Momoh, M.A., and Builders, P.F., 2012, “Lipid Nanoparticulate Drug Delivery Systems: A Revolution in Dosage Form Design and Development” in Recent Advance in Novel Drug Carrrier Systems, Demir, A., eds., InTech, DOI: 10.5572/50486.

[7] Love, A.R., Kerschner, J.L., Barratt, M.J., and Zhou, Y., 2003, Stabilization of resorcinol derivatives in cosmetic compositions, U.S. Patent, 0180234A1.

[8] Toh, M.R., and Chiu, G.N.C., 2013, Liposomes as sterile preparations and limitations of sterilisation techniques in liposomal manufacturing, Asian J. Pharm. Sci., 8 (2), 88–95.

[9] Chang, H.I., and Yeh, M.K., 2012, Clinical development of liposome-based drugs: Formulation, characterization, and therapeutic efficacy, Int. J. Nanomedicine, 7, 49–60.

[10] Jeschek, D., Lhota, G., Wallner, J., and Vorauer-Uhl, K., 2016, A versatile, quantitative analytical method for pharmaceutical relevant lipids in drug delivery systems, J. Pharm. Biomed. Anal., 119, 37–44.

[11] Riswanto, F.D.O., Lukitaningsih, R.R.E., and Martono, S., 2015, Analytical method validation and determination of pyridoxine, nicotinamide, and caffeine in energy drinks using thin layer chromatography-densitometry, Indones. J. Chem., 15 (1), 9–15.

[12] Syukri, Y., Martien, R., Lukitaningsih, E., and Nugroho, A.E., 2016, Quantification of andrographolide isolated from Andrographis paniculata nees obtained from traditional market in Yogyakarta using validated HPLC, Indones. J. Chem., 16 (2),190–197.

[13] Suchocka, Z., Gronostajska, D., Suchocki, P., and Pachecka, J., 2003, New HPLC method for separation of blood plasma phospholipids, J. Pharm. Biomed. Anal., 32 (4-5), 859–865.

[14] Chimanuka, B., Gabriëls, M., Detaevernier, M.R., and Plaizier-Vercammen, J.A., 2002, Preparation of β-artemether liposomes, their HPLC–UV evaluation and relevance for clearing recrudescent parasitaemia in Plasmodium chabaudi malaria-infected mice, J. Pharm. Biomed. Anal., 28 (1), 13–22.

[15] de Mattos, A.C., Khalil, N.M., and Mainardes, R.M., 2013, Development and validation of an HPLC method for the determination of fluorouracil in polymeric nanoparticles, Braz. J. Pharm. Sci., 49 (1), 117–126.

[16] De, A.K., Chowdhury, P.P., and Chattapadhyay, S., 2014, Quantitative analysis of resorcinol from marketed hair tonic using liquid chromatographic technique, Int. Sch. Res. Notices, 2014, 632591.

[17] De, A.K., Chowdhury, P.P., and Chattapadhyay, S., 2016, Simultaneous quantification of dexpanthenol and resorcinol from hair care formulation using liquid chromatography : Method development and validation, Scientifica, 2016, 1537952.

[18] Snyder, L.R., Kirkland, J.J., and Dolan, J.W., 2010, Introduction to Modern Liquid Chromatography, 3rd ed., John Wiley & Sons, Inc., New Jersey.

[19] Dwiastuti, R., Radifar, M., Marchaban, Noegrohati, S., and Istyastono, E.P., 2016, Molecular dynamics simulations and empirical observations on soy lecithin liposome preparation, Indones. J. Chem., 16 (2), 222–228.

[20] Dwiastuti, R., Noegrohati, S., and Istyastono, E.P., 2016, Formulation and physical properties observations of soy lecithin liposome containing 4-n-butylresorcinol, AIP Conf. Proc., 1755 (1), 160005.

[21] Badran, M., Shalaby, K., and Al-Omrani, A., 2012, Influence of the flexible liposomes on the skin deposition of a hydrophilic model drug, carboxyfluorescein: dependency on their composition, Sci. World J., 2012, 134876.

[22] Ermer, J., and Miller, J., 2005, Method validation in pharmaceutical analysis. A Guide to best Practice, Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

[23] Ahuja, S., and Dong, M.W., 2005, Handbook of pharmaceutical analysis by HPLC, vol. 6, 1st ed., Elsevier Academic Press, London.

[24] Şengül, U., 2015, Comparing determination methods of detection and quantification limits for aflatoxin analysis in hazelnut, J. Food Drug Anal., 24 (1), 56–62.

[25] Chan, Y.H., Chen, B.H., Chiu, C.P., and Lu, Y.F., 2004, The influence of phytosterols on the encapsulation efficiency of cholesterol liposomes, Int. J. Food Sci. Technol., 39 (9), 985–995.

[26] MalvernTech, 2012, Guide to dynamic light scattering measurement and analysis, NanoComposix, v1.3, 1–7.

[27] González, A.G., and Herrador, M.Á., 2007, A practical guide to analytical method validation, including measurement uncertainty and accuracy profiles, TrAC, Trends Anal. Chem., 26 (3), 227–238.

[28] Liu, X., Ruan, L., Mao, W., Wang, J., Shen, Y., and Sui, M., 2010, Preparation of RGD-modified long circulating liposome loading matrine, and its in vitro anti-cancer effects, Int. J. Med. Sci., 7 (4), 197–208.



DOI: https://doi.org/10.22146/ijc.28919

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