Objective: To establish a
HPLC - MS method for determining the concentrations of
nisodipine in human plasma and to evaluate the
pharmacokinetics of
sustained - and immediate - release preparations. Method: A C18 column was used to separate nisodipine in plasma with a mobile phase of a mixture of methanol - water - acetic acid (75:25:0. 1) at a flow rate of 1.0 mL ·min-1. Atmosperic pressure electronic spray ionisation( AP -ESI)and ion mass spectral(m/z)of 411 were selected to quantify nisodipine,and 441 for nimodipine(internal standard). Results : The linear range of the standard curve of nisodipine was 0. 2 ~ 50
ng ·mL-1, and the determination limit was 0. 15 ng · mL-1. The extraction recovery was more than 72. 6% ,intra - day and inter - day RSD were less than 9. 8% . After a single dose of 10 mg,the main pharmacokinetics of nisodipine sustained - release tablets,sustained -release capsules and tablets were as follows,t1/2(h)6. 08± 1. 48,7. 06±1. 80,3. 70 ±0. 25;Tmax(h)5. 41 ±0.72, 5.83±0.44,2.02±0.23:Cmax(ng . mL-1)3.43 ±0.55,3.71 ±0.24,9. 18 ± 3. 78: AUC0~t (ng . h . mL-1) 31. 11 ±5. 00,33. 63 ±7. 16,32. 72 ±5. 09,F(% )95. 53 ±11. 66,102. 20 ±9. 32. After multiple doses, Cmax (ng . mL-1)5. 20 ±0.27,3. 91 ±0. 22,5. 30 ±1. 04:Cmin(ng · mL-1)0.72±0. 10,0.77 ±0.07,0.53 ±0.07,DF(%) 175. 00 ±16. 34,177. 10 ±18.43,247.92 ± 57. 71: Cav ( ng · mL-1)1.78±0.18,1.78 ±0.18,1.93±0.33: AUC88 0~t(ng . h ·mL-1)45. 71±3. 50,42. 82 ±4. 39,23. 23 ±3. 98,respectively. Conclusions:The method is sensitive ,fast and accurate. It is suitable for therapeutic drug monitoring and human pharmacokinetic studies of nisodipine.
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