Abstract
A rapid reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of Kanamycin sulphate (KS) in PLGA nanoparticle formulation. A new formulation of KS loaded PLGA nanoparticles (NPs) was prepared by double (multiple) emulsion process in our laboratory. The desired chromatographic separation was achieved on a Phenomenex C18 column under isocratic conditions using UV detection at 205 nm. The optimized mobile phase consisted of a mixture of 0.1 M disodium tetraborate (pH 9.0) and water (25:75, v/v) supplemented with 0.5 g/L sodium octanesulphonate at a flow rate of 1 mL/min. The linear regression analysis for the calibration curves showed a good linear correlation over the concentration range of 120-840 µg/ml, with correlation coefficients of (r2 0.9997). The system was found to construct sharp peaks for KS and IS with retention times of 4.08 and 5.49 min, respectively. Transmission electron microscopy studies on MFX NPs demonstrated particle size < 100 nm. An average encapsulation efficiency of 74.34% was obtained for NPs. In vitro studies showed zero-order release and about 95% drug being released within 12 days in PBS (pH 7.4). In conclusion, the proposed optimized method was successfully applied for the determination of in vitro and in vivo release studies of KS NPs.
Highlights
Kanamycin sulphate (KS) is an aminoglycoside antibiotic which is produced by fermentation of Streptomyces kanamyceticus and is used as sulphate salt (Ogawa et al, 1959; Rothrock et al, 2010)
A rapid reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for the determination of Kanamycin sulphate (KS) in PLGA nanoparticle formulation
KS is an aminoglycoside antibiotic which is produced by fermentation of Streptomyces kanamyceticus and is used as sulphate salt (Ogawa et al, 1959; Rothrock et al, 2010)
Summary
KS is an aminoglycoside antibiotic which is produced by fermentation of Streptomyces kanamyceticus and is used as sulphate salt (Ogawa et al, 1959; Rothrock et al, 2010). KS is used as a second-line drug for the treatment of Multi drug resistance tuberculosis (MDR-TB) (Rybak et al, 2007). KS has a very short plasma half-life (2.5 h). KS is used in high concentrations to reach the therapeutic levels in plasma and tissue, which results in serious ototoxicity/nephrotoxicity, and acquisition of KS resistance-TB (Doluisio et al, 1973; Jain et al, 2012; Selimoglu et al, 2003). KS has been formulated as transdermal patch (Lopez-Cervantes et al, 2009), Freeze dried microparticles for inhalation (Jae-Young et al, 2010), and gold nanoparticles (Kyung-Mi et al, 2011).In order to fully characterize KS formulations or delivery systems such as polymeric NPs, suitable and validated quantification methods are required to assess critical pharmaceutical characterization such as drug content, encapsulation efficiency, in vitro drug release, and in vivo absorption studies
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