| Nymalize (nimodipine) is a type of calcium channel blockers that is used widely to treat adult patients from subarachnoid hemorrhage (SAH). Nimodipine is the only oral solution that has been approved for a treatment from cerebral vasospasm. The objective of this investigation was to develop a new reversed-phase liquid chromatographic (RP-HPLC) method to determine Nymalize (nimodipine) in its raw material and impurities/degradants. The separation of nimodipine and its impurities/degradation products was optimized under isocratic elution technique using Symmetry C8 column (3.9 x 150mm, 5? particle size) made by Waters with a mobile phase composed of 40% methanol and 60% of 25 mM phosphate buffer at pH 7 and a flow rate of 1.0 mL min?1. The injected volume was 15?l of 1000 ppm nimodipine with the column temperature maintained at 25° C. The detection wavelength was adjusted at 238 nm. Under these conditions, nimodipine was retained for 14.00 min.;In this investigation, nimodipine was subjected to acidic, basic, oxidative, thermal and UV light. All degraded peaks were separated from each other and from the nimodipine peak. The developed method was validated under ICH and FDA guidelines. Parameters considered in the validation study were system suitability test, specificity, solution stability, robustness, linearity, accuracy, precision, limit of detection (LOD), and limit of Quantitation (LOQ). |
