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www.orientjchem.org
ISSN: 0970-020 X
CODEN: OJCHEG
2014, Vol. 30, No. (2):
Pg. 905-910
The present study is aimed to develop visible spectrophotometric methods for the
determination of Bendamustine hydrochloride. The developed methods involve the formation of
chloroform extractable colored ion-association complexes of Bendamustine hydrochloride with
tropaeolineo-oo (Method A) and Alizarin Red S (Method B). The chloroform extracted coloured
complexes showed absorbance maxima at wavelengths 480 and 460nm in methods A and B
respectively. Beers law obeyed in the concentration range of 2.512.5 g/mL in both the cases.
Correlation coefficients were found to be 0.9991 and 0.9998 for methods A and B respectively. In
addition molar absorptivity, Sandell sensitivity and the optimum conditions for quantitative analysis
of the Bendamustine hydrogenchloride were determined. The developed ion-association complex
methods were rapid, simple and economically viable compared to other reported analytical methods
which require expensive instruments and are not available in common laboratories. Thus the
proposed methods for Bendamustine determination in bulk and pharmaceutical formulations can
be used in commercial laboratories.
INTRODUCTION
Bendamustine hydrochloride {(4-{5-[bis(2-chloroethyl) amino]-1-methyl-1Hbenzimidazol2-yl} butanoic acid)} (Fig. 1) is a bifunctional
alkylating agent that is used to treat chronic
lymphocytic leukemia (CLL) and non-Hodgkin
lymphoma and may be used for other types of
906
907
Method A
Method B
max (nm)
Beers law limits (mg/ml)
Molar absorptivity (1 mol-1.cm-1)
Sandells sensitivity (mg.cm-2/0.001 absorbance unit)
Optimum photometric range (mg/ml)
Regression equation (Y=a+bc); Slope (b)
Standard deviation on slope (Sb)
Intercept (a)
Standard deviation on intercept (Sa)
Standard error on estimation (Se)
Correlation coefficient (R2)
Relative standard deviation (%)**
% Range of error (confidence limits)
0.05 level
0.01 level
LOD
LOQ
480
2.5 - 12.5
1.145 x 104
0.3254
3.5-10.0
0.028
4.953 x 10-4
0.003
2.857 x 10-3
3.915 x 10-3
0.9991
1.12004
460
2.5-12.5
9.241 x 103
0.3496
3.0-20.0
0.0236
3.0288 x 10-4
0.0024
1.7473 x 10-4
2.3944 x 10-3
0.9998
1.60586
0.93666
1.38548
0.102
1.017
1.34295
1.9864
0.0221
0.0737
Pharmaceutical
Labeled
Formulation
Amount
(Mg)
A
B
Bendit
100.0
Proposed Method
Amount
Found**
(mg) S.D
t
(Value )
F
(Value)
99.90 0.356
100.01 0.336
0.200
0.079
1.207
1.075
908
909
910
application in laboratories
chromatographic instruments.
lacking
liquid
REFERENCES
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