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NK Sathish et al Visible Spectro Photometric Determination of Darifenacin Hydrobromide in bulk and Pharmaceutical dosage forms<br />
Table 1: Optical characteristics and precision data<br />
Parameter Observation<br />
Absorption maxima (nm) 620 nm<br />
Beer ’ s law limit (µg/ml) 5-25 µg/ml<br />
Correlation coefficient 0.9992<br />
Regression equation (y=mx + c)<br />
Slope (m) 0.0133<br />
Intercept (c) -0.0373<br />
Table 2: Assay of commercial formulations.<br />
Formulation Amount Amount % Assay S.D.* % RSD*<br />
labeled found*<br />
(mg) (mg)/tab<br />
DARILONG 7.5 7.475 99.67 0.421 0.422<br />
7.5 Tablets<br />
DARILONG 15 14.842 98.95 0.298 0.301<br />
15 Tablets<br />
Drug name Amount<br />
label<br />
claimed<br />
(μg/ml)<br />
Darifenacin<br />
HBr (Tablet)<br />
DARILONG<br />
7.5<br />
*Average of six determinations. S.D. is standard deviation, RSD is relative standard deviation.<br />
10<br />
10<br />
10<br />
10<br />
10<br />
10<br />
10<br />
10<br />
10<br />
Drug name Amount<br />
label<br />
claimed<br />
(μg/ml)<br />
10<br />
Darifenacin 10<br />
HBr (Tablet)<br />
10<br />
DARILONG 10<br />
15 10<br />
10<br />
10<br />
10<br />
10<br />
Table 3: Recovery study for tablet formulation (I).<br />
Amount of<br />
standard<br />
added<br />
(μg/ml)<br />
5<br />
5<br />
5<br />
10<br />
10<br />
10<br />
15<br />
15<br />
15<br />
Amount of<br />
standard<br />
added<br />
(μg/ml)<br />
5<br />
5<br />
5<br />
10<br />
10<br />
10<br />
15<br />
15<br />
15<br />
Total<br />
amount<br />
recovered<br />
(μg/ml)<br />
14.768<br />
14.918<br />
14.88<br />
19.932<br />
19.826<br />
19.998<br />
24.745<br />
24.863<br />
24.993<br />
Table 4: Recovery studies for tablet formulation (II).<br />
Total<br />
amount<br />
recovered<br />
(μg/ml)<br />
14.892<br />
14.933<br />
14.964<br />
19.952<br />
19.992<br />
19.996<br />
24.985<br />
24.948<br />
24.995<br />
* Avg. of three determinations, S.D. is standard deviation.<br />
47<br />
Abs<br />
0.3<br />
0.2<br />
0.1<br />
0<br />
400 500 600 700 800<br />
Wavelength(nm)<br />
%<br />
Recovery<br />
*<br />
98.45<br />
99.45<br />
99.2<br />
99.66<br />
99.13<br />
99.99<br />
98.98<br />
99.45<br />
99.97<br />
%<br />
Recovery<br />
*<br />
99.28<br />
99.55<br />
99.76<br />
99.76<br />
99.96<br />
99.98<br />
99.94<br />
99.79<br />
99.98<br />
Mean %<br />
Recovery<br />
(± S.D.)<br />
99.36 ± 0.491<br />
Mean %<br />
Recovery<br />
(± S.D.)<br />
99.78 ± 0.235<br />
RJPS, Apr-Jun, 2011/ Vol 1/ Issue 1