CN102095697A - Method for measuring roxithromycin - Google Patents
Method for measuring roxithromycin Download PDFInfo
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- CN102095697A CN102095697A CN 201010579886 CN201010579886A CN102095697A CN 102095697 A CN102095697 A CN 102095697A CN 201010579886 CN201010579886 CN 201010579886 CN 201010579886 A CN201010579886 A CN 201010579886A CN 102095697 A CN102095697 A CN 102095697A
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- roxithromycin
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Abstract
The invention discloses a method for measuring roxithromycin, which comprises the steps of: adding 0.0mL, 0.5mL, 1.0mL, 1.5mL, 2.0mL, 2.5mL and 3.0mL of 0.50-0.55mg/L of roxithromycin solution, 0.5-2.5mL of 4.8-5.2*10-4mol/L ethyl violet solution and 0.2-1.0mL of 0.09-0.15mol/L HCI solution in a colorimetric cylinder of 10mL in sequence; diluting the mixed solution to a scale with secondary distilled water, and shaking uniformly; heating the solution in a water bath at the temperature of 45 to 55 DEG C for 10 minutes, taking out and cooling the solution to the room temperature, measuring the absorbance value A637nm of the mixed solution with the roxithromycin solution and the absorbance value A0 of a reagent blank solution without the roxithromycin at the wavelength of 637nm on an ultraviolet and visible spectrophotometer by using a cuvette of 1cm and taking second distillated water as a reference, and calculating the absorbance difference deltaA637nm which equals to A637nm minus A0; and taking another 2 to 10 roxithromycin tablets or roxithromycin capsules, grinding and mixing uniformly, then weighing 0.0050-0.0250g of the mixture, dissolving the weighed mixture with ethanol and metering the volume, and measuring the absorbance value by the same method. The measuring method has high sensitivity, is simple and convenient to operate, is fast, and has low cost of instruments.
Description
Technical field
The present invention relates to the assay method of Roxithromycin, particularly move the method for reaction spectrphotometric method for measuring Roxithromycin based on the ethyl violet lotus.
Background technology
Roxithromycin is the derivant of Erythromycin A, it is a relative newer semi-synthetic macrolide antibiotics, it has kept original antibacterial activity of erythromycin and bactericidal mechanism, and chemical stability and lipophilicity have been improved, 's the antibacterials of wide spectrum clinically since coming out always, to gram-positive bacteria, comprise that staphylococcus aureus, streptococcus pyogenes, Staphylococcus epidermidis, streptococcus pneumonia and part Gram-negative bacteria and anaerobion, mycoplasma, Chlamydia, Legionella all have stronger antibacterial activity.Roxithromycin has characteristics such as consumption is little, absorption is fast, long action time, its bad reaction be common feel sick, digestive tract reactions such as stomachache, diarrhoea, also can have a headache, dizzy, fash and itch etc., particularly to liver, the bad person of renal function, pregnant woman, women breast-feeding their children want careful usefulness.For scientific and reasonable, use this class microbiotic safely and effectively, setting up accurately and rapidly, the monitoring method of blood concentration is crucial work in the clinical medicine.At present, the main method of measuring Roxithromycin has microbiological assay method (MA), spectrophotometric method, high performance liquid chromatography (HPLC), reversed-phased high performace liquid chromatographic (RHPLC) etc., but the MA method is loaded down with trivial details, time-consuming, can not satisfy anxious clinically urgent patient needs the requirement of fast detecting blood concentration, is eliminated gradually; HPLC method and RHLPC method are measured accurately, but the instrument costliness, the sample pretreatment complexity.Because the spectrophotometric method instrument is simple, swift to operate, cost of determination is low and condition is easy to control, highly sensitive, has become one of indispensable method of Pharmaceutical Analysis.The developer that is used to measure Roxithromycin at present mainly contains cresol red, alizarin, dimethylamino benzaldehyde, purpurin, 7,7,8, and the 8-four cyano is to secondary methylbenzoquinone (TCNQ) etc., and the apparent molar absorption coefficient ε of these methods is 10
3～10
4Lmol
-1Cm
-1Ethyl violet is the bigger reagent of a kind of molar absorptivity, uses morely in analytical chemistry, but has not yet to see report based on the method that the ethyl violet lotus moves reaction spectrphotometric method for measuring Roxithromycin.
Summary of the invention
The purpose of this invention is to provide a kind of method of moving reaction spectrphotometric method for measuring Roxithromycin based on the ethyl violet lotus.
Concrete steps are:
In the 10mL color comparison tube, add 0.0,0.5,1.0,1.5,2.0,2.5 successively, 3.0mL 0.50～0.55mg/L Roxithromycin solution, 0.5～2.5mL 4.8～5.2 * 10
-4Mol/L ethyl violet solution, 0.2～1.0mL, 0.09～0.15mol/L HCl solution is diluted to scale with redistilled water, shakes up.Heating 10min in 45～55 ℃ of water-baths, take out and be cooled to room temperature, on ultraviolet-visible pectrophotometer, use the 1cm cuvette, is reference with the redistilled water, measures respectively at 637nm wavelength place and is added with Roxithromycin solution absorbency value A
637nmThe absorbance A that does not add the blank reagent solution of Roxithromycin
0, calculate absorbance difference Δ A
637nm=A
637nm-A
0, its absorbance difference Δ A
637nmLinear in 0～0.156mg/L scope with the Roxithromycin concentration C, equation of linear regression is Δ A
637nm=3.9904C+0.0065, related coefficient 0.9990, apparent molar absorption coefficient ε
637=3.34 * 10
6Lmol
-1Cm
-1Other gets 2～10 of Roxithromycin sheets (roxithromycin capsules) (grain), takes by weighing 0.0050～0.0250g behind the levigate mixing, with dissolve with ethanol, constant volume, measures absorbance with method, calculates the content of Roxithromycin in the Roxithromycin sheet (roxithromycin capsules).
The principle of the present invention's reaction: Roxithromycin is an electronq donor, and ethyl violet is an electron acceptor, and both can carry out lotus and move reaction.
Assay method of the present invention is a luminosity reagent with the ethyl violet, the method for the mensuration Roxithromycin of being set up highly sensitive, and apparent molar absorption coefficient ε can reach 3.34 * 10
6Lmol
-1Cm
-1Selectivity is good, easy, quick, instrument is inexpensive.
Description of drawings
Fig. 1 is the uv-visible absorption spectra figure of the embodiment of the invention 2 blank and 0.052mg/L Roxithromycin;
Mark among the figure: a: blank; B:0.052mg/LL Roxithromycin-7.6 * 10
-5Mol/L ethyl violet-6.25 * 10
-3Mol/L HCl.
Fig. 2 is reaction principle figure of the present invention.
Embodiment
Embodiment 1:
In the 10mL color comparison tube, add 0.0,0.5,1.0,1.5,2.0,2.5 successively, 3.0mL 0.52mg/L Roxithromycin solution, 1.5mL 5.067 * 10
-4Mol/L ethyl violet solution adds 0.5mL 0.125mol/LHCl solution again, is diluted to scale with redistilled water, shakes up.Heating 10min in 50 ℃ of water-baths, take out and be cooled to room temperature, on ultraviolet-visible pectrophotometer, use the 1cm cuvette, is reference with the redistilled water, measures respectively at 637nm wavelength place and is added with Roxithromycin solution absorbency value A
637nmThe absorbance A that does not add the blank reagent solution of Roxithromycin
0, calculate absorbance difference Δ A
637nm=A
637nm-A
0Its absorbance difference Δ A
637nmWith the equation of linear regression of Roxithromycin concentration C be Δ A
637nm=3.9904C+0.0065, related coefficient 0.9990, apparent molar absorption coefficient ε
637=3.34 * 10
6Lmol
-1Cm
-1Other gets two Roxithromycin sheets (labelled amount 150mg/ sheet) grind into powder, accurate weighing 0.0050g (being equivalent to contain Roxithromycin 2.841mg) behind the mixing, use anhydrous alcohol solution, filter, the filtrate constant volume is (about 20% ethanol) in the 100mL volumetric flask, get then the above-mentioned solution constant volume of 1mL in 50mL volumetric flask (about 20% ethanol) as liquid to be measured, get 1mL liquid to be measured and measure absorbance with method, the above-mentioned regression equation of substitution, the content that calculates Roxithromycin in the Roxithromycin sheet is the 152.7mg/ sheet.
Embodiment 2:
In the 10mL color comparison tube, add 0,0.5,1.0,1.5,2.0,2.5 successively, 3.0mL0.52mg/L Roxithromycin solution, 1.5mL 5.067 * 10
-4Mol/L ethyl violet solution adds 0.5mL0.125mol/LHCl solution again, is diluted to scale with redistilled water, shakes up.Heating 10min in 50 ℃ of water-baths, take out and be cooled to room temperature, on ultraviolet-visible pectrophotometer, use the 1cm cuvette, is reference with the redistilled water, measures respectively at 637nm wavelength place and is added with Roxithromycin solution absorbency value A
637nmThe absorbance A that does not add the blank reagent solution of Roxithromycin
0, calculate absorbance difference Δ A
637nm=A
637nm-A
0, its absorbance difference Δ A
637nmWith the equation of linear regression of Roxithromycin concentration c be Δ A
637nm=3.9904c+0.0065, related coefficient 0.9990, apparent molar absorption coefficient ε
637=3.34 * 10
6Lmol
-1Cm
-1Other gets 3 of roxithromycin capsules (labelled amount 150mg/ grain), its content is all inclined to, mixing, accurately be weighed as 0.8414g, then accurately take by weighing 0.0052g (being equivalent to contain Roxithromycin 2.781mg) again, add anhydrous alcohol solution, filter, constant volume is (about 20% ethanol) in the 100mL volumetric flask, get then the above-mentioned solution constant volume of 1mL in 50mL (about 20% ethanol) volumetric flask as liquid to be measured, get 1mL liquid to be measured and measure absorbance with method, the above-mentioned regression equation of substitution, the content that calculates Roxithromycin in the roxithromycin capsules is the 148.4mg/ grain.
Measure the abosrption spectrogram of Roxithromycin and see Fig. 1.
Claims (1)
1. method of measuring Roxithromycin is characterized in that concrete steps are:
In the 10mL color comparison tube, add 0.0,0.5,1.0,1.5,2.0,2.5 successively, 3.0mL 0.50～0.55mg/L Roxithromycin solution, 0.5～2.5mL 4.8～5.2 * 10
-4Mol/L ethyl violet solution, 0.2～1.0mL, 0.09～0.15mol/L HCl solution is diluted to scale with redistilled water, shakes up; Heating 10min in 45～55 ℃ of water-baths, take out and be cooled to room temperature, on ultraviolet-visible pectrophotometer, use the 1cm cuvette, is reference with the redistilled water, measures respectively at 637nm wavelength place and is added with Roxithromycin solution absorbency value A
637nmThe absorbance A that does not add the blank reagent solution of Roxithromycin
0, calculate absorbance difference Δ A
637nm=A
637nm-A
0, its absorbance difference Δ A
637nmLinear in 0～0.156mg/L scope with the Roxithromycin concentration C, equation of linear regression is Δ A
637nm=3.9904C+0.0065, related coefficient 0.9990, apparent molar absorption coefficient ε
637=3.34 * 10
6Lmol
-1Cm
-1Other get Roxithromycin sheet or 2～10 of roxithromycin capsules or, take by weighing 0.0050～0.0250g behind the levigate mixing, with dissolve with ethanol, constant volume, measure absorbance with method, calculate the content of Roxithromycin in Roxithromycin sheet or the roxithromycin capsules.
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| CN 201010579886 CN102095697B (en) | 2010-12-07 | 2010-12-07 | Method for measuring roxithromycin |
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| CN 201010579886 CN102095697B (en) | 2010-12-07 | 2010-12-07 | Method for measuring roxithromycin |
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| CN102095697B CN102095697B (en) | 2013-07-24 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103776945A (en) * | 2014-01-16 | 2014-05-07 | 扬子江药业集团南京海陵药业有限公司 | Quality control method of roxithromycin capsules |
| CN104713842A (en) * | 2015-03-24 | 2015-06-17 | 河南省奥林特药业有限公司 | Method for evaluating quality of composition for treating deficiency body common cold by employing ultraviolet-visible spectrophotometry |
| CN108254345A (en) * | 2018-01-03 | 2018-07-06 | 桂林理工大学 | A kind of method that roxithromycin is measured based on phloxine |
| CN108318456A (en) * | 2018-01-03 | 2018-07-24 | 桂林理工大学 | A method of roxithromycin is measured based on eosin |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004084911A2 (en) * | 2003-03-24 | 2004-10-07 | Y's Therapeutics Co., Limited | Use of roxithromycin or its derivatives for the modulation of immune responses |
| CN101699255A (en) * | 2009-10-23 | 2010-04-28 | 江苏大学 | Novel method for separating/enriching trace roxithromycin in environment |
-
2010
- 2010-12-07 CN CN 201010579886 patent/CN102095697B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004084911A2 (en) * | 2003-03-24 | 2004-10-07 | Y's Therapeutics Co., Limited | Use of roxithromycin or its derivatives for the modulation of immune responses |
| CN101699255A (en) * | 2009-10-23 | 2010-04-28 | 江苏大学 | Novel method for separating/enriching trace roxithromycin in environment |
Non-Patent Citations (3)
| Title |
|---|
| 《中南药学》 20081031 杨蕾等 茜素红荷移分光光度法测定罗红霉素胶囊含量 576-578 1 第6 卷, 第5 期 2 * |
| 《光谱学与光谱分析》 20030228 赵桂芝等 荷移分光光度法测定罗红霉素 157-159 1 第23 卷, 第1期 2 * |
| 《分析化学》 20030731 李华侃等 罗红霉素与紫色素的荷移反应及其测定 833-835 1 第31 卷, 第7 期 2 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103776945A (en) * | 2014-01-16 | 2014-05-07 | 扬子江药业集团南京海陵药业有限公司 | Quality control method of roxithromycin capsules |
| CN104713842A (en) * | 2015-03-24 | 2015-06-17 | 河南省奥林特药业有限公司 | Method for evaluating quality of composition for treating deficiency body common cold by employing ultraviolet-visible spectrophotometry |
| CN108254345A (en) * | 2018-01-03 | 2018-07-06 | 桂林理工大学 | A kind of method that roxithromycin is measured based on phloxine |
| CN108318456A (en) * | 2018-01-03 | 2018-07-24 | 桂林理工大学 | A method of roxithromycin is measured based on eosin |
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| CN102095697B (en) | 2013-07-24 |
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Effective date of registration: 20151123 Address after: 030600 A zone, Shanxi pharmaceutical industry park, Jinzhong economic and Technological Development Zone, Shanxi Patentee after: SHANXI DEYUANTANG PHARMACEUTICAL CO.,LTD. Address before: 541004 Guilin city of the Guangxi Zhuang Autonomous Region Road No. 12 building of Guilin University of Technology Patentee before: Guilin University of Technology |
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| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: A Method for the Determination of Roxithromycin Effective date of registration: 20220926 Granted publication date: 20130724 Pledgee: Bank of China Limited Jinzhong Branch Pledgor: SHANXI DEYUANTANG PHARMACEUTICAL CO.,LTD. Registration number: Y2022140000052 |
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