Simultaneous determination of fluorometholone and tetrahydrozoline hydrochloride in ophthalmic suspension by HPLC
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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.
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.
참고문헌 (14)
- "The DrugBank database"[URL]
- "The DrugBank database"[URL]
- E. B. Ozgurhan, , BioMed Res. Int., 2013, pp.1~8 (2013)
- R. I. El-Bagary, , J. Chromatogr. Sci., 54(6), pp.923~933 (2016)[DOI]
- F. Al-Rimawi, , J. Pharm. Anal., 2(1), pp.67~70 (2012)[DOI]
- M. S. Ali, , J. Chromatogr. Sci., 40, pp.429~433 (2002)[DOI]
- Medicines & Healthcare Products Regulatory Agency, "British Pharmacopoeia", ~ (2016)
- The Directorate for the Quality of Medicines & HealthCare of the Council of Europe (EDQM), "The European Pharmacopoeia", ~ (2014)
- The United States Pharmacopeial Convention, "The United States Pharmacopeia, USP 39 NF 34", ~ (2016)
- The Ministry of Health, Labour and Welfare, "The Japanese Pharmacopoeia", ~ (2016)
- Ministry of Food and Drug Safety, "The Korean Pharmacopoeia", ~ (2014)
- "ICH Guideline. Q2(R1): validation of Analytical Procedures: Text and Methodology Q2(R1) in ICH Harmonised Tripartite Guideline", ~ (2005)
- "Ministry of Food and Drug Safety No. 2009-173", ~ (2009)
- "Ministry of Food and Drug Safety, No. C0-2012-2-005", ~ (2012)