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Method development and validation of Ipratropium bromide by HPLC.

Landage SS, Shembade SH, Tamboli AM

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.