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A New Stability Indicating RP-HPLC Method for the Quantification of Trifluridine Using an Ion Pairing Agent
被引:0
|作者:
Eluru, Jajili
[1
]
Annapurna, Mukthinuthalapati Mathrusri
[1
]
机构:
[1] Gandhi Inst Technol & Management Deemed Univ, GITAM Sch Pharm, Dept Pharmaceut Anal, Visakhapatnam, Andhra Pradesh, India
关键词:
ICH guidelines;
reversed-phase high-performance liquid chromatography;
stability indicating;
stress degradation studies;
trifluridine;
validation;
D O I:
暂无
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
Introduction: Trifluridine is a trifluoro thymidine derivative used to treat viral infections of eyes. A new stability indicating reversed-phase high-performance liquid chromatography (HPLC) method was developed and validated for the determination of trifluridine in pharmaceutical dosage forms (ophthalmic solution). Materials and Methods: Shimadzu Model CBM-20A/20 Alite HPLC system with PDA detector and Agilent C18column were used for the present study. Mobile phase mixture consisting of tetra butyl ammonium hydrogen sulfate and methanolin the ratio 48: 52, v/v with a flow rate 1.0 mL/min was chosen for the chromatographic elution of Trifluridine (Detection wavelength 265 nm). Results and Discussion: The method was linear over the concentration range 0.1-100 mg/ml with linear regression equation, y = 43421x + 2389.5 (R-2 = 0.9999). The limit of quantitation and limit of detection were found to be 0.0971 mg/ml and 0.0311, respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines. Conclusion: The proposed RP-HPLC method is simple, precise, robust, accurate and can be applied for the routine analysis of Trifluridine dosage forms.
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页码:544 / 550
页数:7
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