RP-HPLC/ELSD METHOD DETERMINATION OF ... - Ijsidonline.info

Viswanath Reddy Pyreddy et al., IJSID 2011, 1 (2), 126-133LSU400.00200.000.00Topiramate - 4.081400.00LSU200.004.0820.00400.00LSU200.004.0820.00400.00LSU200.004.0830.00LSU400.00200.004.089LSU2.001.501.000.500.000.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00MinutesFigure-4: System suitability solutionTopiramate - 4.0810.00-0.501.00 2.00 3.00 4.00 5.00 6.00MinutesFigure-5: Overlaid chromatogram of diluent and standard solutionInternational Journal of Science Innovations and Discoveries Vol 1, Issue 2, September-October 2011130

Viswanath Reddy Pyreddy et al., IJSID 2011, 1 (2), 126-133LSU0.800.600.400.20Topiramate - 4.0970.00-0.201.00 1.50 2.00 2.50 3.00 3.50 4.00 4.50MinutesFigure-6: Overlaid chromatogram of Placebo and Test solutionPrecision: In case of intra-day precision, %RSD was found to be in the range of 1.2-1.4. In case of inter-dayprecision, %RSD was found to be in the range of 0.91-1.20. Reproducibility results were tabulated in table-3.ParameterTable-3: Reproducibility Results.Sample preparationsPrep-1 Prep-2 Prep-3 Prep-4 Prep-5 Prep-6AveragePrecision 101.1 98.9 99.6 99.2 100.5 101.4 100.11Intermediate Precision 101.5 100.8 100.38 100.1 99.6 99.4 100.29Recovery study: Accuracy of the method was confirmed by recovery study from marketed sample at three level ofstandard addition. % Recovery for topiramate was found to be 98.5-102.5. results were tabulated in table-4.Table-4: Accuracy Results.Spike level %25% 50% 75% 100% 125% 150%Recovery101.1 100.1 99.6 99.2 101.5 100.8 100.38Linearity: The linearity of Topiramate was found to be in the range of 500-3000ppm with correlation coefficient0.983. Linearity chromatograms were represented in figure-7 and results were shown in Table-5.(%)International Journal of Science Innovations and Discoveries Vol 1, Issue 2, September-October 2011131

Viswanath Reddy Pyreddy et al., IJSID 2011, 1 (2), 126-1331000.00L SU800.00600.00400.00T opiram ate - 4.097200.000.003.50 3.60 3.70 3.80 3.90 4.00 4.10 4.20 4.30 4.40 4.50 4.60 4.70 4.80 4.90MinutesFigure-7: Linearity solutionsTable-5: Linearity Results.Linearity Level Concentration (ppm) Peak area1 500 1561832 1000 8192753 1500 16809724 2000 27326385 2500 39554386 3000 5867372Co-relation Coefficient 0.983261Robustness and Robustness: The robustness was checked by small but deliberate change in two parameters likemobile phase flow rate0.9ml/min to 1.1 ml/min, mobile phase composition ±10% organic modifier. Overall %RSDwas found to be 0.40. The robustness data are shown in table for two parameters like mobile phase flow rate,mobile phase composition. Robustness data is shown in Table 6.Table-6: Robustness Results.System suitability ResultsParameter (Variation) USP %RSD forTailing 5replicate std.inj.0.9ml/min 1.0 0.6Flow rate1.0ml/min 0.9 0.81.1ml/min 1.0 0.990% ratio 1.1 1.0Organic100% ratio 1.0 0.7variation(acetonitrile)110% ratio 0.8 0.9LimitTailing factor:Not more than 2.0%RSD:Not more than 2.0%CONCLUSIONA specific, accurate, precise and robust isocratic HPLC-ELSD method has been developed for thedetermination of Topiramate in pharmaceutical products. The recovery studies revealed excellentaccuracy and high precision of the method. Therefore the proposed method could be applied for routineanalysis in quality control laboratories.International Journal of Science Innovations and Discoveries Vol 1, Issue 2, September-October 2011132

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