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L. Bhaskar Reddy et al., IJSID 2011, 1 (1), 33-40Graph-1: Linearity GraphPrecision: Precision of the analytical method is expressed as the series of the measurement. It wasascertained by replicate estimation of the drug by the proposed methods. Method precision wasdemonstrated by the assay of six samples, prepared as described above, on different systems, analystsand columns. Results were calculated and tabulated in table-2.International Journal of Science Innovations and Discoveries VOL1, Issue 1, July-August 201138
L. Bhaskar Reddy et al., IJSID 2011, 1 (1), 33-40Table-2: Precision ResultsResults (% of assay)S. No. Losartan Hydrochlorothiazid Enalapril MaleatePotassiumePrecisionInt.Precision Precision Int.PrecisionPrecision Int.Precision1 99.17 99.4 99.8 101.2 99.9 99.62 98.9 100.2 101.5 99.5 98.7 98.93 100.1 99.8 100.4 98.7 99.5 98.44 99.8 99.9 99.9 99.3 99.2 99.35 99.5 101.1 98.9 99.4 98.6 99.76 99.1 99.7 99.7 98.9 99.4 100.1Average 99.42 100.01 100.03 99.5 99.21 99.33%RSD 0.46 0.59 0.87 0.89 0.50 0.61Accuracy: Accuracy of each of the proposed method was ascertained on the basis of recovery studiesperformed by the addition of standard to placebo solution and recovery results found to be satisfactory.Results were tabulated in talbe-3Table-3: Recovery ResultsSample No. Spiked Level Recovery % of recovery1 50 99.682 50 98.999.483 50 99.871 100 100.102 100 99.8999.963 100 99.91 150 99.72 150 98.999.463 150 99.8Ruggedness: The stability study of Standard preparation and test preparation on bench top wasconducted at Initial, after 1 day and 2 days. The test preparation and standard preparation wereestimated against freshly prepared standard every time. The difference in percentage assay of testpreparation from initial up to 2days results were found to be within the accepted criteria. The similarityfactor for standard preparation from initial to 2 days should be in the range of 0.98 to 1.02 and was foundto be within the limits. Standard solution was prepared as per test method and system suitabilityparameters were evaluated by using the same lot of Mobile phase each time. The system suitability wasfound to be within the Limits.Robustness: A study was conducted to determine the effect of slight changes in the chromatographicconditions such as flow rate, mobile phase composition, pH of the mobile phase and filter validation. TheInternational Journal of Science Innovations and Discoveries VOL1, Issue 1, July-August 201139
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