Development and validation of a stability-indicating LC method for determining

仪器资料 · 发表于 2018-9-18 14:50:52

Development and validation of a stability-indicating LC method for determining Palonosetron hydrochloride, its related compounds and degradation products using naphthalethyl stationary phase
A selective and simple reversed phase HPLC method using naphthalethyl stationary phase was developed
and validated for the quantitative determination of Palonosetron hydrochloride (PALO), its related
compounds and degradation products. Chromatographic separation (Rs > 2) was achieved with linear
gradient mode of elution at a flow rate of 1 mL/min and with UV detection at 210 nm. The intra and
inter-day coefficients of variation were less than 1.0% (RSD). Consistent recoveries were obtained for
PALO (99.2–100.5%) and its impurities (90.0–104.8%). All the analytes exhibited excellent linearity with
R2 value greater than 0.998. Limit of detection (LOD) and limit of quantification (LOQ) were determined
to be in the range 0.011–0.013 g/mL and 0.035–0.046 g/mL respectively. The test solution was found
to be stable up to 5 days. Induced degradation methods were applied to study the degradation behavior
of the drug. LC–MS was used to analyze the degraded samples and possible structural identifications
were assigned based upon known reactivity of the drug and molecular weights. The m/z values matched
with the hydroxylated, keto and N-oxide metabolites of PALO. The stress samples were assayed against
a qualified reference standard and the mass balance was found close to 99.9%.

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