Abstract Objective: To determine the content of quinapril hydrochloride tablets by high performance liquid chromatography. Method: A C18 chromatographic column was used. Methanol: water: phosphoric acid: diethylamine (160: 40: 0.13: 0.16) was the mobile phase, and the ultraviolet detection wavelength was 215 nm. Results: The average recovery rate was 99.60%, and RSD = 0.12% met the requirements. Conclusion: This method is feasible.
Keywords: Quinapril hydrochloride; high performance liquid chromatography; content determination. Hypertension is a common cardiovascular disease, most of which is primary, requiring long-term antihypertensive treatment. Over the past 30 years, new products of antihypertensive drugs have been continuously developed. Quinapril hydrochloride, as an angiotensin-converting enzyme inhibitor, has a light to moderate strength antihypertensive effect and has been widely used in clinical treatment. The content of quinapril hydrochloride tablets is an important indicator of its quality control. The detection method is high performance liquid chromatography, which has the characteristics of high separation efficiency, fast analysis speed and high sensitivity.
1 Instrument and test equipment: Japan Shimadzu LC-1OA high performance liquid chromatography analyzer: SPD-10AP) detector, LC-10A TVP high pressure infusion pump, C-R7A plus data processor.
Test drug: Quinapril hydrochloride reference substance, provided by China National Institute for the Control of Pharmaceutical and Biological Products; methanol. Phosphoric acid and diethylamine are chromatographically pure, and water is purified water.
2 Methods and results
2.1 Preparation of reference substance solution: Weigh accurately 20mg of quinapril hydrochloride reference substance, put it in a 50ml volumetric flask, add water to dissolve and dilute to the mark.
2.2 Preparation of test solution: Take 20 quinapril hydrochloride tablets, remove the coating, and weigh about 20mg. Place in a 50ml volumetric flask. Add water and dilute to the mark. Shake well and filter.
2.3 Chromatographic conditions, chromatographic column: C "column, octadecylsilane-bonded silica gel as a filler; methanol: water: phosphoric acid: diethylamine (160: 40: 0.13: 0.16) as the mobile phase; flow rate 1.1 ml / min; column temperature 40 ℃; ultraviolet detection wavelength is 215nm.
2.4 System suitability test: 20μl of the reference solution was injected into the chromatograph and separated under the above chromatographic conditions. The retention time of quinapril hydrochloride was about 11min from the chromatogram; the theoretical plate number was quinapril hydrochloride peak Calculated as 2700 (≥1000), the resolution of the quinapril hydrochloride peak and the adjacent impurity peak is 4.2.
2.5 Precision test: Weigh precisely 5 samples of the same batch of quinapril hydrochloride, operate according to the sample determination method, and the area of ​​its baseline constitutes the peak area. A = × σ × h = 2.507σh = 1.064 Wh / 2h> The relative standard deviation of the peak area measurement value is 0.20%, and the precision is good.
2.6 Repeatability test: take 2μl of the reference solution, repeat the injection 5 times under the above chromatographic conditions, the peak area RSD = 0.12%, good reproducibility.
2.7 Recovery rate test: using sample recovery, accurately weigh 7 samples of quinapril hydrochloride with the determined content, add the reference substance accurately, prepare the test solution according to the method of sample solution preparation, inject, record Chromatography, calculate the recovery rate, the average recovery rate is 99.60%. '
2.8 Determination of sample: Precisely measure 2μl of the test solution into the chromatograph, measure under the above chromatographic conditions, and record the chromatogram; measure the reference substance solution in the same way, and calculate the peak area according to the external standard method. Puli is 98.53% of the marked amount.
3 Discussion The above determination shows that the determination method has a suitable sample retention time, the number of theoretical plates can meet the requirements, the method is simple and feasible, and is suitable for the determination of the content of quinapril hydrochloride tablets.
references
[1] An Dengkui, drug analysis [M]. Jinan, Jinan Publishing House, 1992.5
[2] Zhou Tonghui, Analytical Chemistry Handbook [M]. Beijing, Chemical Industry Press, 1997.
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