The present work was focused on the development and validation of High-Performance Liquid
Chromatography (HPLC) method which is simple, rapid, precise, accurate, sensitive, and economical
for the quantitation of Ipratropium bromide in bulk and capsule dosage form has been validated. The
chromatographic separation was attained on Agilent zorbax bonus-RP column with dimensions (250 × 4.6
mm, 5μ) particle size employing 0.1% Trifluoroacetic acid and Acetonitrile (ACN) in the ratio of 70:30%
v/v as mobile phase, which was pumped at a rate of 1.0 ml/min and detected at a wavelength of 210 nm. The
linearity of the method was demonstrated in the concentration range of 24-56 μg/ml for Ipratropium bromide
with a correlation coefficient (r²) of 0.999. Percentage drug recovery was found to be 99.03%-100.08%, and
percentage relative standard deviation was <2%. Limit of detection and limit of quantification values were
found to be 1.15 μg/ml and 3.49 μg/ml, respectively, and assay of marketed capsule formulation was found to
be 99.44%. The developed HPLC method was found to be simple, specific, sensitive, rapid, linear, accurate,
precise, and economical and could be used for regular quality control of Ipratropium bromide in bulk and
capsule formulation.
Author(s): Landage SS, Shembade SH, Tamboli AM
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