SINGLE RP-HPLC METHOD FOR THE ... - Ijsidonline.info

Hari Kishan Reddy Ganthi et al., IJSID, 2012, 2 (4), 471-490Table 23: % degradation data for 100/500/15 mg tabletsAceclofenacParacetamolStress Condition%degradation%degradationAcid degradation 0.1N HCl, 1hr at 60°C 10.7 3.6Alkali degradation 1N NaOH, 1hr at 80°C 98.6 19.2Peroxide degradation 6% H 2O 2, 2hrs at 80°C 17.4 2.5Thermal degradation 2 hrs at 80°C 8.2 3.0Photolytic degradation 1.2 m.lux hrs 8.2 3.0Solution Stability Studies:Mobile phase stability at room temperature:The mobile phase was prepared as per the proposed test method and kept at room temperature for a period of two days inwell closed condition. The system suitability solutions were prepared and injected into the HPLC system at initially andperiodically after 1day. The system suitability parameters were evaluated. The mobile phase was also observed for Physicalchanges like haziness or precipitation. System suitability results are tabulated in Table 24.Table 24: Mobile phase stability at room temperatureSr. No.System Suitability parameterObservationsInitialDay-1The % RSD of peak area Aceclofenac 0.2 0.11 response for five replicate Paracetamol 0.2 0.2injectionsChlorzoxazone 0.1 0.1Aceclofenac 6737 67042 Theoretical platesParacetamol 3013 3227Chlorzoxazone 10870 10725Aceclofenac 1.9 1.83 Tailing factorParacetamol 1.3 1.2Chlorzoxazone 1.0 1.0Analytical Solution Stability (Standard and Test preparation) at room temperature:International Journal of Science Innovations and Discoveries, Volume 2, Issue 4, July-August 2012LimitsNMT 2.0NLT 1000NMT 2.0Standard and test preparations were prepared as per the proposed test method and the stock solutions were kept at roomtemperature. The solutions were diluted freshly at each time and injected into the HPLC system at initially and at differenttime intervals. The % difference in area was calculated against the fresh standard solution injected at each time interval.The % difference in area response was evaluated against the initial assay value. The results are tabulated in Table 25, 26and 27.Table 25: Stability of Aceclofenac Standard and test solution at room temperatureAceclofenac StandardAceclofenac TestTime (Hours) Area Response % Difference Area Response % DifferenceInitial 3549534 NA 3598615 NA4 Hrs 35 min 3539237 0.3 3578216 0.68 Hrs 3540881 0.2 3609559 0.312 Hrs 15 min 3559542 0.3 3597509 0.016 Hrs 20 min 3546836 0.1 3575222 0.720 Hrs 25 min 3540089 0.3 3575272 0.623 Hrs 3557104 0.2 3571046 0.824 Hrs 30 min 3528644 0.6 3562606 1.029 Hrs 3532159 0.5 3581784 0.533 Hrs 3581358 0.9 3581157 0.540 Hrs 50 min 3630421 2.3 3581119 0.5482