Development and Validation of a Stability-Indicating RP-UPLC Method for the Quantitative Analysis of Sparfloxacin

Abstract

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.

Analytical methods for determination of new fluoroquinolones in biological matrices and pharmaceutical formulations by liquid chromatography: a review

“…Gupta et al [73] achieved similar results for SPA although the samples were submitted to the above conditions for different times (8 h as opposed to 12 h in the case of LEV). Under photolytic conditions (4-min exposure to UVA radiation) and thermal stress (60°C for 64 h) significant degradation of GEM was found.…”

“…In the case of tablets, these are individually weighed and pulverized to obtain a homogeneous mixture and an appropriate amount of the resultant powder is thereafter dissolved in a selected solvent and sonicated to facilitate solubilisation. Finally, each sample is filtered through a suitable filter and injected into the chromatographic system [58,73,[128][129][130][131]. For eye drops and injectable solutions, dilution is the only procedure that is performed [58,73,129].…”

“…As a result of considerable efforts devoted to the optimization of the chromatographic steps involved, it is nowadays a proven and well-established technique [73].…”

“…This technique allows a reduction of analysis time and improvement of resolution and sensitivity [73]. The small-sized particles of the UPLC technology provide narrower peaks, increasing the theoretical plate number and subsequently resolution; because the height of narrower peaks is higher, an increase in sensitivity is also obtained.…”

Development and Validation of New Rp-Uplc Method for the Determination of Cefdinir in Bulk and Dosage Form

“…Drug analysis is performed by various analytical methods like spectral methods, electroanalytical methods and chromatographic methods. HPLC has proven to be predominant technology used in laboratories worldwide during past 30 y [2,3]. High-performance liquid chromatography (HPLC) is one mode of chromatography, one of the utmost used analytical techniques.…”