Dr. Ajay Kaparwan, Dr. Sanjay Poman
, Mumbai Analytical Laboratory, Navi Mumbai, India
Here we demonstrate an application for Besifloxacin in ophthalmic suspension on RP-HPLC using Chromolith® SpeedROD RP-18e column for system suitability, linearity, repeatability, percentage recovery, LOD and LOQ.
Besifloxacin (Figure 1) is a bactericidal fluoroquinolone-type antibiotic, used for the treatment of bacterial conjunctivitis caused by susceptible bacteria. It was approved by US FDA in May 2009. Here, a solution is demonstrated for the determination of Besifloxacin in ophthalmic suspension dosage using HPLC with a monolith column and UV Detection at 289 nm. At present, there are no pharmacopeial monographs available for the assay of Besifloxacin in ophthalmic suspension dosage forms.
Figure 1.Chemical Structure of Besifloxacin
Figure 2.Chromatograms of a) Besifloxacin reference STD solution; b) Besifloxacin test solution; and c) Blank solution (diluent)
Figure 3.LOQ and LOD chromatograms of Besifloxacin overlaid with blank
Figure 4.Linearity plot of Besifloxacin reference standard
An isocratic RP-HPLC method for the determination of Besifloxacin in ophthalmic suspension was developed using Chromolith® SpeedROD RP-18 endcapped column with UV detection at 289 nm. The experimental data indicated an excellent linearity with an r2 value of 0.999 (Figure 4) for the selected concentration range (0.005 – 75 µg/mL, Table 4). The LOD and LOQ values were estimated as 2.3 µg/mL and 7 µg/mL, respectively. The method precision for assay was below 1% RSD and the percentage recovery found to be ranging from 102.1 -104 % (Table 5).
In conclusion, the data for linearity, system suitability, repeatability of the method suggests its aptness for the assay of Besifloxacin in opthalmic suspension using Chromolith® SpeedROD RP-18 endcapped column.
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