Objective:An improved stability indicating RP-HPLC method was developed for the estimation of Troxipide in bulk and tablet dosage forms. Method:Chromatographic separation of Troxipide from its degradation products was achieved on Agilent Zorbax SB-CN (150 × 4.6 mm, 3.5 μm) using sodium phosphate buffer (pH was adjusted to 4.0 ±0.05) and acetonitrile in the ratio of 40:60 v/v, at a flow rate of 0.8 mL/min.mL/min. This system was found to give compact peak for Troxipide at 2.1±0.2 min. The detection was monitored at 260 nm. Results: The linear regression data for the calibration plots showed good relationship with r2 = 0.99 ± 0.001. The method was validated for precision, linearity, accuracy and robustness according to International Conference…show more content… Accurately weighed and transferred the quantity equivalent to 10 mg of troxipide into a 10 mL volumetric flask. Added 7 mL of diluent and sonicated to dissolve it completely and made volume up to the mark with diluent and mixed well.Further pipetted3.0mL of the stock solution into a 10mL volumetric flask and diluted the volume with diluent mixed well. Further pipetted3mL of the solution into a 10mL volumetric flask and diluted up to the mark with diluent. Mixed well and filtered through 0.45µm filter. The chromatogram of the commercial sample was shown in figure 3. Assay result was shown in table 1.
The optimized chromatographic method was completely validated according to the procedures described in ICH guidelines Q2 (R1) and Q1 A (R2) for the validation of analytical methods and stability testing of new drug respectively.
Linearity is the ability of the method to elicit the test results.Aliquot of standard troxipide stock solution was taken and calibration curve was plotted between peak areas against drug concentration.Troxipide was found to be linear in the range of 10-60 μg/mL with correlation coefficient of 0.999. The calibration curve was shown in figure 4.
The system precision was evaluated by injecting five replicate injections of standard and % RSD was calculated. The % RSD was found to be 0.5…show more content… The author was thankful to the Andhra University,Vizag and Jawaharlal Technological University, Kakinada, for their support to carry out this research work.
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