Factory high quality Zolmitriptan

Superiority:

139264-17-8 - Physico-chemical Properties

139264-17-8 - Reference

This product contains zolmitriptan (C16H21N302) should be the label amount of 90.0% ~ 110.0%.

trait

This product is white or white-like tablets or film-coated tablets, white or white-like after removing the coating.

identification

1. take an appropriate amount of the fine powder of this product (about 10mg of Zolmitriptan), put it in a dry plug test tube, add 20mg malonic acid and 20 drops of acetic anhydride, and heat it in a boiling water bath for 1-3 minutes, the solution was red-brown in color.
2. in the chromatogram recorded under the content determination item, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.
3. take an appropriate amount of fine powder of this product and add 0.1 mol/L hydrochloric acid solution is dissolved and diluted to prepare a solution containing about 5ug of Zolmitriptan per 1 ml, filtered, and then the filtrate is taken and determined by UV-Vis spectrophotometry (General 0401), there is a maximum absorption at 222nm and 283nm wavelengths, and a minimum absorption at a wavelength of 247mn.

examination

• relevant substances: take an appropriate amount of the fine powder of this product, add the mobile phase to dissolve and dilute to prepare a solution containing about 0.5mg of Zolmitriptan per 1ml, filter, and take the continued filtrate as the test solution; take 1ml of precision, 100ml flask, diluted with mobile phase to scale, shake, as a control solution. The determination was carried out according to the method for the related substances of Zolmitriptan. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) the area of the main peak of the control solution, and the sum of the areas of each impurity peak shall not be greater than the area of the main peak of the control solution (1.0%). The chromatogram of the test solution is 0.01 times smaller than the main peak area of the control solution, and the peak is negligible (0.01%).
• R-isomer take an appropriate amount of the fine powder of this product (approximately equivalent to 50mg of Zolmitriptan), put it in a 100ml measuring flask, add 0.1 mol/L hydrochloric acid solution dissolved and diluted to the scale, shake, filter, take the filtrate as a test solution; Precision take 1 ml, 200ml flask, with 0.1 mol/L hydrochloric acid solution was diluted to the scale and shaken to serve as a control solution. If there are chromatographic peaks with the same retention time as the R-isomer in the chromatogram of the test solution determined by the method under the R-isomer of zomitriptan, the peak area shall not be greater than the main peak area of the control solution (0.5%). The content uniformity shall be calculated based on the content of each tablet measured under the content determination item, and shall comply with the regulations (General rule 0941).
• dissolution of this product, according to the dissolution and release determination method (General 0931 first method), with 0.1 mol/L hydrochloric acid solution (100 ml) was used as dissolution medium, rotating at RPM, operated according to law. After 30 minutes, the solution was filtered, and the filtrate was continued as the test solution, the solution containing 5ug(2.5mg specification) or 10%(5mg specification) per 1 ml was prepared by precision weighing, dissolving and diluting with dissolution medium as a reference solution. According to the chromatographic conditions under the content determination item, take 10ul of each of the reference solution and the test solution, respectively inject the human liquid chromatograph, and record the chromatogram. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
• others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).

Content determination

• measured by high performance liquid chromatography (General 0512).
• chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler (Ultimate XB C18,4.6mm X 250mm, 5um or equivalent column), with phosphate solution (take potassium dihydrogen phosphate 6.8g, sodium heptane sulfonate l.Olg was dissolved in water and diluted to 6.0 ml, adjusted to pH with triethylamine-acetonitrile (82:18) as mobile phase; Detection wavelength was 224nm. The number of theoretical plates shall not be less than 2000 based on Zolmitriptan peak, Zolmitriptan peak and adjacent impurities
• the resolution between peaks shall meet the requirements.
• determination Method: Take 10 tablets of this product and put them in 100ml measuring flask (2.5mg specification) or 200m l measuring flask (5mg specification) respectively, and add appropriate amount of mobile phase, ultrasonic dissolution of zolmitriptan and dilution of the mobile phase to the scale, shake well, filter, take the filtrate as the test solution, and inject 20u1 into the liquid chromatograph to record the chromatogram •, an appropriate amount of Zolmitriptan reference substance was weighed accurately, dissolved and diluted with mobile phase to prepare a solution containing about 25ug per 1 ml, which was determined by the same method. According to the external standard method, the content of each tablet is calculated by the peak area, and the average content of 10 tablets is obtained.

category

Same as zolmitriptan.