Stability-Indicating HPLC and RP-TLC Determination of Cefpirome Sulfate with Kinetic Study

Two sensitive and selective stability-indicating methods were developed for the determination of the antibiotic cefpirome sulfate in bulk powder, pharmaceutical formulation and in presence of its acid, alkaline, photo- and oxidative degradation products. Method A was based on HPLC separation of cefpirome sulfate in the presence of its degradation products on a reversed phase column C18, 250 × 4.6 mm, 5-μm particle size and mobile phase consisting of 0.1 M disodium hydrogen phosphate dihydrate pH 3.9 adjusted with phosphoric acid–acetonitrile (85:15, v/v). Quantitation was achieved with UV detection at 270 nm. The linear calibration curve was in the range 5.0–50.0 μg mL^?1. Method B was based on reversed phase TLC separation of the cited drug in the presence of its degradation products followed by densitometric measurement of the intact drug at 270 nm. The separation was carried out using disodium hydrogen phosphate dihydrate 2.0 g %w/v, at pH 3.5 adjusted with phosphoric acid–acetone (15:10, v/v) as a developing system. The calibration curve was in the range of 1.0–10.0 μg/spot. The HPLC method was used to study the kinetic of cefpirome sulfate acid degradation. The results obtained were statistically analyzed and compared with those obtained by applying the official Japanese method.