Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
48, Number 1, January 2010, pp. 1-6
Development and Validation of a Stability-Indicating
RP-UPLC Method for the Quantitative Analysis of Sparfloxacin
Himanshu Gupta1, M. Aqil1, R.K.
Khar1, Asgar Ali1,
Aarti Sharma2, and Prakash Chander3,
1Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard
(Hamdard University), New Delhi-110062, India;
2Ranbaxy Research Laboratories,
Gurgaon, India; and 3Waters India Pvt. Ltd., A-41, Sector 62, Noida, India
A rapid, specific, and sensitive ultra-performance
liquid chromatographic (UPLC) method for quantitative analysis
of sparfloxacin in bulk drug and pharmaceutical formulations
has been developed and validated. In this work, a new gradient
reversed-phase chromatographic method was developed. The newly
developed method is applicable for assay determination of the
active pharmaceutical ingredient. The chromatographic separation
of sparfloxacin was achieved on a Waters Acquity HSS T-3 column
(100 × 2.1 mm, 1.8 µm) within a short runtime of
5 min. The method was validated according to the ICH guidelines
with respect to system suitability, linearity, limit of quantitation
and detection, precision, accuracy, robustness, and specificity.
Forced degradation studies were also performed for sparfloxacin
bulk drug samples to demonstrate the stability indicating power
of the UPLC method. Comparison of system performance with conventional
HPLC was made with respect to analysis time, efficiency, and
sensitivity. The developed method was applied for the assay of
marketed sparfloxacin formulations like tablets and eye drops.
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