. 2019; 16(1): 0-0

A Validated RP-UPLC Method for the Determination of Gemifloxacin Mesylate in Bulk and its Pharmaceutical Preparation.

Hebatallah A Wagdy1, Mohamed Tarek1, Ahmed Amer2, Menna Gamal2, Mohey Elmazar3
1Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, The British University in Egypt (BUE), Cairo, Egypt.
2The Center for Drug Research and Development (CDRD), Faculty of Pharmacy, The British University in Egypt, Cairo, Egypt.
3Pharmacology and Toxicology Department, Faculty of Pharmacy, The British University in Egypt (BUE), Cairo, Egypt

INTRODUCTION: Gemifloxacin Mesylate is a fourth generation fluoroquinolone antibacterial agent. A simple, accurate and precise reversed phase UPLC method was developed and validated for short time analysis of Gemifloxacin Mesylate in its bulk and pharmaceutical preparation.
METHODS: The optimum separation was achieved at 0.5±0.03 min using AcclaimTM RSLC 120 C18 column 2.2μm (2.1 x 100 mm) at 30°C by isocratic mobile phase at pH= 3.0 composed of acetonitrile: phosphate buffer (25mM) with ratio 75: 25 (v/v). The column effluents were monitored at 276 nm using photo diode array detector (PDA) at flow rate 0.5 mL/min. The method was validated according to ICH guidelines.
RESULTS: The linearity of the calibration curve ranged from 0.5μg/mL to 10 μg/mL and square of the regression coefficient (r2) was 0.9991. The % RSD of inter-day precision ranged from 0.081% to 1.233%, while for intra-day ranged from 0.364 % to 1.018%. The method was found accurate with % recovery ranging from 93.71% to 100.29 % and % RSD ranged from 1.054 to 2.722. The limit of detection (LOD) and the limit of quantification (LOQ) were 0.066 and 0.2 μg/mL.
DISCUSSION AND CONCLUSION: The validated method proof its ability for the assay of Gemifloxacin mesylate in its bulk and dosage form in short time (less than 1 minute). To the best of our knowledge, this is the first RP-UPLC method for the determination of Gemifloxacin mesylate.

Keywords: Gemifloxacin Mesylate, Ultra performance liquid chromatography, Method validation


Hebatallah A Wagdy, Mohamed Tarek, Ahmed Amer, Menna Gamal, Mohey Elmazar. A Validated RP-UPLC Method for the Determination of Gemifloxacin Mesylate in Bulk and its Pharmaceutical Preparation.. . 2019; 16(1): 0-0

Corresponding Author: Hebatallah A Wagdy, Egypt


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