Determination of Loteprednol Etabonate and the Related Substances in Loteprednol Etabonate and Tobra-mycin Compound Ophthalmic Suspension by HPLC with Gradient Elution
- VernacularTitle:HPLC梯度洗脱法测定氯替泼诺妥布霉素复方混悬滴眼液中氯替泼诺含量及有关物质
- Author:
Longhua YANG
;
Wenjing XUE
;
Jie SU
;
Jingguang LU
- Publication Type:Journal Article
- Keywords:
Loteprednol etabonate and tobramycin compound ophthalmic suspension;
Content;
Related substances;
HPLC;
Gra-dient elution
- From:
China Pharmacist
2016;19(9):1794-1796
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop an HPLC with gradient elution method for the determination of loteprednol etabonate and the re-lated substances in loteprednol etabonate and tobramycin compound ophthalmic suspension. Methods:HPLC with gradient elution was performed with Inertsil ph phenyl column (250 mm × 4. 6 mm, 5 μm). The mobile phase A and B was 0. 25% acetic acid solution-acetonitrile (80 ∶20) and acetonitrile, respectively. The flow rate was 2. 0 ml·min-1 and the detection wavelength was 244 nm. The column temperature was 30 ℃ and the injection volume was 20 μl. Results:The main ingredient and the related substances could be well separated. Loteprednol etabonate had a good linear relationship within the range of 0. 001-1. 02 mg·ml-1(r=0. 999 9), and the average recovery was 99. 9%(RSD=0. 9, n=9). Conclusion:The assay method is sensitive, accurate and convenient with good res-olution. It can be applied to control the quality of loteprednol etabonate and tobramycin compound ophthalmic suspension.
