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- E-ISSN 2288-8985
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- P-ISSN1225-0163
- E-ISSN2288-8985
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Simultaneous determination of fluorometholone and tetrahydrozoline hydrochloride in ophthalmic suspension by HPLC
분석과학 / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2018, v.31 no.2, pp.88-95
https://doi.org/10.5806/AST.2018.31.2.88
(강원대학교)
(강원대학교)
(강원대학교)
(강원대학교)
(강원대학교)
(충남대학교)
(대구가톨릭대학교)
(중앙대학교)
((재)한국보건공정서연구회)
(강원대학교)
(강원대학교)
(강원대학교)
(강원대학교)
(강원대학교)
(충남대학교)
(대구가톨릭대학교)
(중앙대학교)
((재)한국보건공정서연구회)
(강원대학교)
Thuy-Vy,
P.
,
Xuan,
L.
M.
,
송하람,
안수빈,
차민정,
강종성,
우미희,
나동희,
전인구,
&
김경호.
(2018). . 분석과학, 31(2), 88-95, https://doi.org/10.5806/AST.2018.31.2.88
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Abstract
A simple, sensitive, and selective high-performance liquid chromatography (HPLC) method was developed and validated for the simultaneous quantification of fluorometholone (FLU) and tetrahydrozoline hydrochloride (THZ) in combined ophthalmic formulations. The effects of several factors, including detection wavelength, buffer pH, buffer concentration, and organic solvent concentration, on the performance of the method were investigated. The performance of the developed method was validated in accordance with the requirements of the International Conference on Harmonization. The linearity of the calibration curves in the desired concentration range was high for both FLU and THZ (r2 = 0.9999). The accuracy and precision of the method were determined by a recovery study at analyte concentrations of 80 %, 100 %, and 120 %. The recovery was 99.60–100.17 % for both analytes, with a relative standard deviation less than 1.0 % at any concentration level. The validated results indicate that the new HPLC method could be successfully applied for the simultaneous determination of FLU and THZ in ophthalmic suspensions.
- keywords
- HPLC, Fluorometholone, Tetrahydrozoline hydrochloride, Determination, Validation, Ophthalmic suspension
참고문헌
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The DrugBank database, https://www.drugbank.ca/drugs/DB00324.
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The DrugBank database, https://www.drugbank.ca/drugs/DB06764.
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The United States Pharmacopeial Convention, The United States Pharmacopeia, USP 39 NF 34, United States (2016).
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The Ministry of Health, Labour and Welfare, The Japanese Pharmacopoeia, 17th Edition, Japan (2016).
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Ministry of Food and Drug Safety, The Korean Pharmacopoeia, 11th Edition, Republic of Korea (2014).
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ICH Guideline. Q2(R1): validation of Analytical Procedures: Text and Methodology Q2(R1) in ICH Harmonised Tripartite Guideline (2005).
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Ministry of Food and Drug Safety No. 2009-173 (2009. 12. 15), Republic of Korea.
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Ministry of Food and Drug Safety, No. C0-2012-2-005 (2012. 09. 19), Republic of Korea.
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