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Research Article Open Access
The present study was aimed to develop an analytical method for determination of Diclofenac Sodium SEDDS formulation in hard gelatin capsules by High Performance Liquid Chromatography (HPLC) method. The HPLC method was developed using chromatopack, Inertsil C18, 250x4.6mm, 5μm analytical column, simple mobile phase containing mixture of Methanol: Buffer in the ratio of 60:40 v/v, at flow rate of 1.0mL/min using wavelength at 254nm. The retention time of Diclofenac sodium was about 14 minutes. The method was validated for its specificity, accuracy, precision, and linearity, limit of detection (LOD), limit of quantification (LOQ), robustness and stability parameters. This method was applied to analyse the finished formulation without interference of excipients present in the formulation. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 5-150 μg/mL for Diclofenac Sodium. The method showed good recoveries (98.0 to 101.5%). The proposed method was suitable for quantitative and entrapment efficiency determination of Diclofenac Sodium in SEDDS formulation in hard gelatin capsules. On the other hand, this HPLC method is allowed for elimination of the interference of the SEDDS lipophilic components dissolved in the buffer medium and no difference was observed between the results of this analysis in comparison with HPLC results.
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Author(s): A. V. Gotoskar, J. Bhat M