Development and validation of a stability-indicating RP-UPLC method for the quantitative analysis of sparfloxacin.
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 x 2.1 mm, 1.8 microm) 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.
Gupta
Himanshu
H
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard (Hamdard University), New Delhi-110062, India. himanshu18in@yahoo.com
Aqil
M
M
Khar
R K
RK
Ali
Asgar
A
Sharma
Aarti
A
Chander
Prakash
P
D000995:Antitubercular Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D024841:Fluoroquinolones / Q000032:analysis*; D009883:Ophthalmic Solutions / Q000737:chemistry; D012680:Sensitivity and Specificity; D013607:Tablets; D013997:Time Factors
D000995:Antitubercular Agents; D024841:Fluoroquinolones; D009883:Ophthalmic Solutions; D013607:Tablets; C061363:sparfloxacin