Résumé
Objective To establish a UHPLC method for the determination of zolpidem tartrate tablets after radiation, and to investigate the effect of different radiation doses on the content of zolpidem tartrate tablets. Methods Ultra high performance liquid chromatography was used. The content of zolpidem tartrate tablets irradiated by γ-ray was determined. Using C18 column, acetonitrile methanol-0.05 mol/L phosphoric acid solution (the pH value as 5.5 with triethylamine) (18∶26∶56) was used as the mobile phase. The flow rate was 0.7 ml/min, and the detection wavelength was 254 nm. Results The method validation showed good linearity in the concentration range of 5-80 μg/ml (r=0.999 6); The average recovery was 98.2%, RSD was 1.72%, and the repeatability was 0.87%. The contents of zolpidem tartrate were 105.1%, 106.4%, 102.7% and 105.4% under 0, 8, 25 and 80 kGy radiation. Conclusion UHPLC has accurate results with short analysis cycle in this study. It is suitable for the determination of zolpidem tartrate tablets after radiation. The content of zolpidem tartrate tablets remained basically unchanged after radiation.
Résumé
OBJECTIVE: To givesafety recommendations for the dose, time of administration, and precautions for zolpidem tartrate. METHODS: Search relevant websites and databases, the pharmaceutical characteristics, clinical application, adverse reactions, drug interactions and rational use of zolpidem tartrate were reviewed. RESULT:S In order to ensure the safety of medication for patients, it is recommended that women and the elderly aged 65 years and above should use the minimum effective dose of 5 mg•d-1. Short-term use, the course of medication should not exceed 4 weeks. Insomnia patients can choose to treat as needed (intermittent, not every night). Follow the prescribed course of treatment and dosage in strict accordance with the doctor's advice. CONCLUSIONS: Zolpidem tartrate can treat various types of insomnia with definite curative effect and mild adverse reactions.Clinicians and pharmacists should pay attention to the safety risks of zolpidem and inform patients of the contraindications and precautions.
Résumé
OBJECTIVE:To establish a method for determination of trace platinum in zolpidem tartrate. METHODS:Graphite furnace atomic absorption spectrometry(GFAAS)was adopted for direct determination after dissolving sample in 1% Hydrochloric acid solution. Horizontal platform graphite tube was performed with detection wavelength of 244.79 nm,slit width of 0.2 nm and current intensity of hollow cathode lamp of 6 mA. The mode of background correction was zeeman effect,the peak height was used as measurement pattern,and the injection volume was 20 μl. RESULTS:The linear range of platinum was 0-100 ng/ml(r=0.999 0);RSDs of precision and reproducibility tests were no more than 2.0%;recovery was 97.78%-103.07%(RSD=1.6%,n=9);the detection limit was 1.48 ng/ml. CONCLUSIONS:This method is simple and rapid with good precision and accuracy,and can be applied for the determination of trace platinum in zolpidem tartrate.
Résumé
OBJECTIVE:To establish a method for the content determination of zolpidem tartrate in microsamples of rat plas-ma. METHODS:Rats were given zolpidem tartrate solution 3 mg/kg intragastrically,and 0.2 ml blood sample were collected and isolated. 50 μl plasma was precipitated by methanol,and the supernatant was determined by HPLC-fluorescence combined with ex-ternal method. Agilent HC-C18 column was used with mobile phase consisted of 0.03 mol/L KH2PO4 solution(containing 0.2% tri-ethylamine)-methanol (33∶67,V/V) at flow rate of 1.0 ml/min. The excitation and emission wavelengths were 254 nm and 390 nm,respectively. The sample size was 20 μl. RESULTS:The linear ranges of zolpidem tartrate in plasma was 2-200 μg/L(r=0.999 7),and the limit of quantification was 2 μg/L. The method recoveries of zolpidem were (96.96 ± 1.35)%-(105.0 ± 5.36)%(RSD=2.20%-4.88%,n=5),and extraction recoveries were (79.72 ± 0.01)%-(80.77 ± 0.02)%(RSD=1.34%-3.90%,n=5). The intra-day and inter-day RSDs were 1.40%-5.10% and 3.22%-9.25%(n=5),respectively. CONCLUSIONS:The method is simple,sensitive and suitable for the content determination of zolpidem tartrate in microsamples of plasma.
Résumé
The objective of this study was to evaluate the difference in the pharmacokinetics of zolpidem tatrate in subjects from five Chinese ethnicities (Han, Mongolian, Uigur, Korean and Hui). Healthy subjects (10 Hans, 10 Mongolians, 10 Uigurs, 10 Koreans and 9 Huis) were recruited and each received a 10 mg tablet-dose of zolpidem tatrate. A total of 12 plasma samples were collected over a 12 h period after administration. The concentrations of zolpidem in plasma were determined by an HPLC-FLU method, after which the pharmacokinetic parameters were determined using DAS 2.0 software and analyzed by SPSS 16.0 software. After normalization by weight, no differences were noted in the pharmacokinetic parameters of zolpidem tatrate among the five ethnic groups (P>0.05). However, there were statistically significant differences between males and females for the pharmacokinetic parameters (P<0.05). The metabolism of zolpidem tatrate in males was faster than in females. Results indicate that ethnicity has no significant impact on the pharmacokinetics of zolpidem tatrate after a single oral dose in healthy Chinese subjects. However, an effect of gender on the pharmacokinetics of zolpidem tatrate can be noted.
Résumé
Two simple, precise and accurate first derivative spectrophotometric methods were developed for the determination of Zolpidem Tartrate in pharmaceutical formulations in phosphate buffer pH 6.8 and acetate buffer pH 4.0. Beer’s law was obeyed over the concentration range 0.5-20 μg/ml in both phosphate buffer (pH 6.8) (Method A) and acetate buffer (pH 4.0) (Method B). The regression equations were found to be y = 0.101x+0.012 (r2 = 0.999) and y = 0.064x+0.009 (r2 = 0.999) in Method A and B respectively. The % RSD in precision studies was found to be 0.28-0.69 (Intra-day) and 0.31-0.73 (Inter-day) for Method A and 0.25-0.82 (Intra-day) and 0.26-0.57 (Inter-day) for Method B respectively. The % RSD in accuracy studies was also found to be 0.14-0.19 (Method A) and 0.18-0.23 (Method B) with percentage recovery 98.67-99.78 and 98.56-99.83 Method A and B respectively.
Résumé
OBJECTIVE: To investigate the pharmacokinetics of zolpidem tartrate tablet in Han healthy volunteers. METHODS: 10 Han health volunteers were given 10 mg zolpidem tartrate tablet via p.o. The plasma concentrations were determined by HPLC-fluorescence method and the pharmacokinetic parameters were calculated by DAS 2.0.1 software. RESULTS: The plasma concentration-time curve of zolpidem tartrate is fitted to one-compartment model with a first order absorption. The main pharmacokinetic parameters were as follows: tmax(0.9?0.5)h,Cmax(190.8?70.6)?g?L-1, t1/2(2.2?0.6)h,Vd/F(0.938?0.256)L?kg-1, CL/F (18.09?10.22)L?h-1, AUC0～12(624.9?190.8) ?g?h?L-1, AUC0～∞(650.1?208.4)?g?h?L-1. CONCLUSION: The pharmacokinetic parameters of zolpidem tartrate in healthy volunlteers are concordant with that stated in literature reports, which can be the basis of pharmacokinetic study in people of different nationalities.