Abstract
A simple, precise, #stability indicating RP-HPLC method was developed
and validated for determination of Besifloxacin HCl (Besi) in bulk
sample and application of that method for estimation of drug i.A
Box–Behnken statistical design with three factors and five levels was
employed
to optimize the #chromatographicconditions. The separation was achieved
using solvent system combination using methanol:Acetonitrile:
phosphate buffer pH 3(25:25:50). The developed method was validated for #linearity, #precision, #accuracy, limit of detection and limit of
quantitation, and robustness in accordance with the ICH guidelines. The
method was found linear with regression coefficient of over a wide
range of 2.5–15 μg/mL. All the #validationparameters were found to be
within the acceptance range. The developed method was successfully
applied to estimate the amount of #Besifloxacin HCl in pharmaceutical
formulations.
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