single rp-hplc method for the estimation of losartan ... - Ijsidonline.info

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L. Bhaskar Reddy et al., IJSID 2011, 1 (1), 33-40Figure-2: Chromatogram of three active ingredients.Validation of Method:System Suitability: Having optimized the efficiency of a chromatographic separation the quality of thechromatography was monitored by applying the following system suitability tests: Resolution, tailingfactor and theoretical plates. The system suitability method acceptance criteria set in each validation runwere: Resolution >2.0, tailing factor ≤2.0 and theoretical plates >2000. In all cases, the relative standarddeviation (R.S.D) for the analyte peak area for two consecutive injections was < 2.0%. A chromatogramobtained from reference substance solution is presented in Figure-3.Figure-3: Chromatogram of standard solution.Specificity: The excipients in the tablets used in this study contained the following inactive ingredients:microcrystalline cellulose, lactose, corn starch, magnesium stearate, hydroxypropyl cellulose,International Journal of Science Innovations and Discoveries VOL1, Issue 1, July-August 201136
L. Bhaskar Reddy et al., IJSID 2011, 1 (1), 33-40hydroxypropyl methylcellulose, titanium dioxide. The capsules tested contained lactose, corn starch,magnesium stearate and colloidal silicon dioxide as excipients. Injections of placebo tablet solutionsshowed no interference with the main peak.Range of linearity: Standard curves were constructed daily, for three consecutive days, using sixdifferent concentrations in a range 50 to 100 μg/ml for all actives. This concentration range correspondsto levels of 50-150% w/w of the nominal analytical concentration. The linearity of peak area responsesversus concentrations was demonstrated by linear least square regression analysis. The linearity ofcorrelation coefficient of Losaratin Potassium is 0.999, Enalapril maleate is 0.999 andHydrochlorothiazide is 0.999. Results were tabulated in table-1, overlaid chromatograms wererepresented in figure-4. Linearity graph plotted between area and concentration and represented ingraph-1.LinearitylevelTable-1: Linearity resultsLinearity ResultsLosartan Potassium Hydrochlorothiazide Enalapril MaleateConc.Area Conc. Area Conc. Area(ppm)(ppm)(ppm)1 50 239629 50 199926 50 1271212 60 285466 60 234067 60 1476083 70 334490 70 265294 70 1693714 80 380586 80 304913 80 1896665 90 424743 90 338487 90 2115316 100 481017 100 378888 100 235212Correlationcoefficient0.9995 0.9993 0.9997Figure-4: Overlaid linearity chromatogramsInternational Journal of Science Innovations and Discoveries VOL1, Issue 1, July-August 201137
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