DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF THREE-COMPONENT IN TABLET DOSAGE FORMULATION

RUPALI S JOSHI*, SAMEER S. KATIYAR, DEVENDRA B. ZOPE, AMOL T. SHINDE

Abstract


ABSTRACT:
An accurate, simple, reproducible and
sensitive method for the determination of
paracetamol, caffeine and chlorpheniramine
maleate in tablet dosage form is developed and
validated. The separation is achieved using
HiQsilC18HS reverse-phase column (250 X 4.6
mm I.D., particle size 5μm) using a mixture of
acetonitrile and water in the proportion 55:300
with final pH of 2.4 adjusted with o-phosphoric
acid as a mobile phase. The flow rate is 1.0
mL/ min and effluents were monitored at 265
nm. Total run time is less than 12 min. and
retention time of paracetamol, caffeine and
chlorpheniramine maleate are 6.742, 9.417, and
3.683 min respectively. Validation of method is
done as per ICH guideline for accuracy,
precision, linearity, specificity, and sensitivity.
The linearity for paracetamol is found to be
100-650 μg/mL where as for caffeine and
chlorpheniramine maleate is found in the range
of 15-100 μg/mL. Result of validation study is
found statistically significant because all the
statistical parameters were within the
acceptance range (COV and S.D. <1.0 for both
accuracy and precision). The limits of detection
(LOD) values are 1.2014, 0.4587 and 0.8945
and limit of quantitation (LOQ) values are
0.5142, 0.4512 and 0.7845 μg/mL for
paracetamol, caffeine and chlorpheniramine
maleate respectively. High percentage recovery
and low COV value revealed the reliability of
the method for quantitative study of three
drugs in Fevril tablets as a quality-control tool
for routine quantitative determination of
paracetamol, caffeine and chlorpheniramine
maleate.


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