B. S. SUNDAR ET AL.
537
The best-fit linear equation obtained was Y = 36422x
+ 338053. At all concentration leve ls, standard deviation
of peak area was significantly low and RSD was below
1.0%. Analysis of residuals indicated that residuals were
scattered within ± 2.0% with respect to 100% concentra-
tion response.
3.3.3. Accu racy
The percentage recovery of amlexanox in bulk drug
samples ranged from 98.86% - 101.05% [Table 2].
3.3.4. Robustness
Close observation of analysis results for deliberately
changed chromatographic conditions (flow rate, pH and
column temperature) revealed that the resolution be-
tween closely eluting degradant in basic condition and
amlexanox was always greater than 2.5, illustrating the
robustness of the method [Table 3].
3.3.5. Solution Stability and Mobile Phase Stability
The %RSD of assay of amlexanox during solution stabil-
ity and mobile phase stability experiments was within
1.0% RSD. No significant changes were observed in the
content of amlexanox during solution stability and mo-
bile phase stability experiments. The solution stability
and mobile phase stability experiments data confirms
that sample solutions and mobile phase used during as-
say and related substance determination were stable up to
the study.
3.3.6. Ass ay Analysis
Analysis was performed for different batches of amlex-
anox in bulk drug samples (n = 3) ranged from 99.5% -
100.2%.
Table 2. Results of Accuracy study for Bulk drugs.
Added (g)
(n = 3) %Recovery for
Bulk drugs %RSD for
Bulk drugs
48 101.05 0.23
60 100.27 0.39
72 98.86 0.04
n =3, Number of determinations
Table 3. Results of robustness study.
S. No Parameter Variation Resolution (Rs)
between base degradant
and Amlexanox
1 Temperature (a) At 20˚C
(b) At 30˚C 2.8
2.9
2 Flow rate
(a) At 0.8 mL·min–1
(b) At 1.2 mL·min–1 2.9
2.7
3 pH (a) At 4.7
(b) At 4.9 2.8
2.7
4. Conclusions
The Stability Indicating RP-LC method developed for
quantitative determinatio n of amlexanox in bu lk drugs is
precise, accurate and specific. The method was com-
pletely validated showing satisfactory data for all the
method validation parameters tested. The developed
method is stability indicating and can be used for the
routine analysis of production samples and also to check
the stability of amlexanox sample.
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