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Determination of sulfate tablets Micronomicin method of dissolution

Micronomicin sulfate tablets to the determination of the quality standards using microbial assays. But this method does not apply to the determination of dissolution. Based on the sulfuric acid in acid medium Micronomicin acid with acetone had a formaldehyde to produce a stable absorption in the ultraviolet region of the adjacent pyridine derivatives, dihydro-dimethyl-principle, the sulfate tablets were Micronomicin dissolution samples with satisfactory results. 1 material 1) Instruments: RC-3B of drug dissolution tester Shimadzu UV-26O f spectrophotometer (Japan production). 2) reagent: sulfuric acid Micronomicin standard (Pharmaceutical and Biological Products available), sulfuric acid Micronomicin materials (Jiangxi Pharmaceutical limited liability company,[link widoczny dla zalogowanych], then the Ministry of Health standards for compliance testing.) Tablet excipients (Nanchang China by Pharmaceutical Co. Ltd.). Has acid acetone, formaldehyde, acetic acid, boric acid, phosphoric acid were of analytical grade. 3) Preparation of reagent buffer: Ball acetic acid 11.5ml, boric acid l2.4g, phosphate 13.5g home 1000ml graduated cylinder. Water near the scale, with 1mol / L sodium hydroxide solution PH value adjusted to 2.6, add water to the mark. Shake well. Alternate preparation of reagent f derivatives: acetyl acetone 1.4m1. 50ml volumetric flask were set formaldehyde 2.8m1, add buffer to the mark. 1 Pro with a new allocation. 2 Methods and Results 1) standard curve: precision weighed dried at 105 ℃ to constant weight of sulfuric acid Micronomicin standard 0.04210g. Purchase 100ml volumetric flask, add water to dissolve and dilute to volume. Shake well. Precision drawing standard solution 1.0,3.0,5.0,[link widoczny dla zalogowanych],7.0,90 m1. Were set to 50ml volumetric flask,[link widoczny dla zalogowanych], add water to the degree of shaking, respectively,[link widoczny dla zalogowanych], Standard dilution of precision drawing of each residue 3ml, set a test tube with stopper, add derivatization reagent 30m1, Mesa, shake, boiling water bath heating 30rain, cooled to room temperature operation with the same method 3.0ml water and 3.0ml derivatization reagent blank. Determination of the 356l'lrn nm absorbance and the standard curve, the results show that the concentration of sulfuric acid Micronomicin 8 ~ 76t ~ g / ml range and absorbance was linear. Regression equation: A = 0.00692C a 3.30 × 10 a, a 0.99972) Determination of sulfate tablets Micronomicin 6, according to Chinese Pharmacopoeia 1995 edition of two 66-page appendix first dissolution test method to 900ml of water as the medium, rotating basket speed 100T/min, according to operation. At l0, 2O,[link widoczny dla zalogowanych], 30,40,5 O, 60m [n each sampling 3.0m1. Filtration, the precision obtained filtrate 1.5ml. Purchase a test tube with stopper. Water 1.5ml. Add derivatization reagent 3.0ml, Mesa, shake, boiling water bath heating 30rain. Cool to room temperature. Micronomicin sulfate standard for synchronous operation control solution, was measured at 356nm wavelength absorption. And calculate the time of release. Relations based on time and release. Dissolution of the same sample as 4Omin. Dan dissolution rate of not less than the cumulative percentage 8o. Attached. Snow mold Schedule sulfate small percentage of things attributed to the cumulative release tablets (= 6), 3) recovery test: Micronomicin sulfate tablets. Sulfate, accurately weighed raw materials and excipients Micronomicin. Dubbed the equivalent of sulfuric acid tablets 100 tablets Micronomicin powder, grind and mix. Accurately weighed amount (about the equivalent of sulfuric acid Micronomicin 0.05g), set 100ml volumetric flask, add water to the mark. Shake the filtrate 5.0m1 precision drawing set 5Oml flask, add water to the mark, shake well. Precision drawing 3.0m1 fixture plug test tube, add derivatization reagent 3. Om1, the following determination of the same operation by 2.2, according to standard uptake value of the recovery rate was 99.8. The relative standard deviation RSD = 0.4s. A 6.3 Results The statistical results of dissolution test, using Weibull probability paper the cumulative dissolution of each batch of extracted parameters. Analysis of variance, P <0.05, statistically significant results. 4 Dan spectrophotometry, as I discussed setting Micronomicin sulfate tablets dissolution. In practice. I think we should pay attention to two points (1) derivatization reagent is very unstable. When you use the new allocation. (2) sulfuric acid Micronomicin acetone and had a reaction of formaldehyde on the PH value of the derivative demanding, so to ensure that buffer PH value of 26. (Editor: Luo Fang)