Development and validation of stability-indicating high performance liquid chromatography method to analyze gatifloxacin in bulk drug and pharmaceutical preparations |
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| Authors: | Ibrahim A. Aljuffali Mohd. Abul Kalam Yasmin Sultana Ahamad Imran Aws Alshamsan |
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| Affiliation: | aNanomedicine Research Unit, Department of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box: 2457, Riyadh 11451, Saudi Arabia;bDepartment of Pharmaceutics, Faculty of Pharmacy, Hamdard University, New Delhi 110062, India;cKing Abdullah Institute for Nanotechnology, King Saud University, P.O. Box: 2455, Riyadh 11451, Saudi Arabia;dPrince Salman Bin Abdulaziz Chair for Kidney Disease, King Saud University, Riyadh 11451, Saudi Arabia |
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| Abstract: | 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® 516 C-18-DB, 50306-U, HPLC column (250 mm × 4.6 mm, 5 μm) 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 °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 μg.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. |
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| Keywords: | Gatifloxacin HPLC Method validation Accelerated stability Solid lipid nanoparticles |
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