A new stability indicating chiral reverse phase high performance liquid chromatography method for determination of degradation products in orphenadrine citrate .pdf
An enantiomeric separation of stability-indicating high performance liquid chromatographic method was developed and validated for the analysis of orphenadrine enantiomers. The degradation behaviour of orphenadrine was investigated under different stress conditions recommended by International Conference on Harmonization (ICH). Enantiomeric resolution of the drug and complete separation from its degradation products were successfully achieved on a Phenomenex® lux cellulose 1 C18 (250 mm × 4.6 mm i.d, 5 μm particle size) column, using UV detector at a wavelength of 241 nm, with mobile phase consisting of acetonitrile, 20mM ammonium bicarbonate at the ratio of 75:25 (v/v), and a flow rate of 1 mL/min. The drug was subjected to alkaline, acidic, neutral, oxidative and photolytic conditions in order to mimic stress conditions. The degradation products were well resolved from main peak and, proving the stability-indicating power of the method. The developed method provided linear responses within the concentration range 2 - 10 μg/mL, and regression analysis showed a correlation coefficient value (r2) of 0.999. The HPLC method was validated as per ICH guidelines with respect to specificity, precision, linearity and robustness. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.50 μg/mL and 2.00 μg/mL, respectively.