Development and validation of stability-indicating high performance liquid chromatography method to analyze gatifloxacin in bulk drug and pharmaceutical preparations

作者：Aljuffali Ibrahim A; Kalam Mohd Abul; Sultana Yasmin; Imran Ahamad; Alshamsan Aws^*

来源：Saudi Pharmaceutical Journal, 2015, 23(1): 85-94.

DOI：10.1016/j.jsps.2014.06.005

• Gatifloxacin
• HPLC
• Method validation
• Accelerated stability
• Solid lipid nanoparticles

Quantitative determination of gatifloxacin in tablets, solid lipid nanoparticles (SLNs) and eye-drops using a very simple and rapid chromatographic technique was validated and developed. Formulations were analyzed using a reverse phase SUPELCO (R) 516 C-18-DB, 50306-U, HPLC column (250 mm x 4.6 mm, 5 mu m) and a mobile phase consisting of disodium hydrogen phosphate buffer: acetonitrile (75: 25, v/v) and with orthophosphoric acid pH was adjusted to 3.3 The flow rate was 1.0 mL/min and analyte concentrations were measured using a UV-detector at 293 nm. The analyses were performed at room temperature (25 +/- 2 degrees C). Gatifloxacin was separated in all the formulations within 2.767 min. There were linear calibration curves over a concentration range of 4.0-40 mu g.mL(-1) and correlation coefficients of 0.9998 with an average recovery above 99.91%. Detection of analyte from different dosage forms at the same Rt indicates the specificity and stability of the developed method.

• 出版日期2015-1