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[Comparison of bioavailability between nimotop and nimodipine tablet]
1Division of Clinical Pharmacy of Huashan Hospital, Shanghai Medical University, Shanghai 200040.
Yao Xue Xue Bao = Acta Pharmaceutica Sinica
|October 13, 2001
Summary
A new HPLC method accurately measures nimodipine plasma levels. A bioavailability study found that a Chinese-made nimodipine tablet had lower bioavailability compared to the German-made nimotop.
Area of Science:
- Pharmacokinetics
- Analytical Chemistry
Background:
- Nimodipine is a crucial drug for treating cerebral vasospasm.
- Accurate quantification of nimodipine in plasma is essential for bioavailability studies.
Purpose of the Study:
- To develop and validate a novel High-Performance Liquid Chromatography (HPLC) method for determining nimodipine plasma concentrations.
- To apply this method to assess and compare the bioavailability of a generic nimodipine tablet (Tablet A) against a branded formulation (Nimotop).
Main Methods:
- Developed an HPLC method using a YWG-C18 column with a methanol-water mobile phase and UV detection at 358 nm.
- Validated the method for linearity, precision, and recovery, achieving high accuracy (recoveries 97.67%-102.3%).
- Conducted a crossover bioavailability study in 8 volunteers comparing Tablet A and Nimotop at a 120 mg oral dose.
Main Results:
- The HPLC method demonstrated excellent linearity (R²=0.9999) within the 5-300 ng/mL range.
- Within-day and between-day precision were below 3% and 5% RSD, respectively.
- Tablet A showed significantly lower bioavailability compared to Nimotop, suggesting formulation or manufacturing differences.
Conclusions:
- The developed HPLC method is reliable and suitable for nimodipine pharmacokinetic studies.
- Tablet A requires formulation and technological improvements to enhance its bioavailability.
- The findings highlight the importance of analytical method validation in drug product evaluation.