2003 Vol. 21, No. 6
Display Method:
2003, (6): 341-343.
Abstract:
OBJECTIVE To establish the method of assay for the bacterial endotoxin in papaverine hydrochlo-ride and sodium chloride injection. METHODS Inhibition and enhancement test was performed with limulus ameboeytc lysate manufactured by two different companies. RESULTS:The injection will not interfere to the bacterial endotoxins test. CONCLUSIONS The results suggest that bacterial endotoxins test(gel-clot method)can be used as an replaceable method for the rabbit pyrogen test for papaverine hydrochloride and sodium chloride injection.
OBJECTIVE To establish the method of assay for the bacterial endotoxin in papaverine hydrochlo-ride and sodium chloride injection. METHODS Inhibition and enhancement test was performed with limulus ameboeytc lysate manufactured by two different companies. RESULTS:The injection will not interfere to the bacterial endotoxins test. CONCLUSIONS The results suggest that bacterial endotoxins test(gel-clot method)can be used as an replaceable method for the rabbit pyrogen test for papaverine hydrochloride and sodium chloride injection.
2003, (6): 343-345.
Abstract:
OBJECTIVE To establish an HPLC method for the determination of zoledronic acid for injection. METHOD:The analysis was achieved by using Diamonsil C18 column with acetonitrile-ion-pair buffer solution(25:75)as mobile phase and UV-detector at wavelength 210nm. The ion-pair buffer solution was a mixture of 0.02mmo1/mL tetrabutyl ammonium hydroxide and 0.02mmo1/mL ammonium dihydrogen phosphate adjusted pH 2.3 with 50% phosphoric acid RESULTS:The linear range was from 50 to 240μg/mL(r=1.0). The average recovery was 100.0%(RSD=0.4%).CONCLUSIONS This method is simple,sensitive,accurate and suitable for the determination of zoledronic acid for injection.
OBJECTIVE To establish an HPLC method for the determination of zoledronic acid for injection. METHOD:The analysis was achieved by using Diamonsil C18 column with acetonitrile-ion-pair buffer solution(25:75)as mobile phase and UV-detector at wavelength 210nm. The ion-pair buffer solution was a mixture of 0.02mmo1/mL tetrabutyl ammonium hydroxide and 0.02mmo1/mL ammonium dihydrogen phosphate adjusted pH 2.3 with 50% phosphoric acid RESULTS:The linear range was from 50 to 240μg/mL(r=1.0). The average recovery was 100.0%(RSD=0.4%).CONCLUSIONS This method is simple,sensitive,accurate and suitable for the determination of zoledronic acid for injection.
2003, (6): 345-346.
Abstract:
OBJECTIVE To establish a HPLC method for the determination of Geniposide in Qingkailing Solution. METHODS The column Shimadzu ODS was used. The mobile phase was acetonitrile and water(15:85). The detection wavelength was 238nm. RESULTS:The average recoveries was 97.53% with the RSD=0.95%(n=6). The standard curve was linear over the range of 0.2554-1.2768μg(r=0.9997). CONCLUTION:The results showed that the method is sensitive,simple,specific.
OBJECTIVE To establish a HPLC method for the determination of Geniposide in Qingkailing Solution. METHODS The column Shimadzu ODS was used. The mobile phase was acetonitrile and water(15:85). The detection wavelength was 238nm. RESULTS:The average recoveries was 97.53% with the RSD=0.95%(n=6). The standard curve was linear over the range of 0.2554-1.2768μg(r=0.9997). CONCLUTION:The results showed that the method is sensitive,simple,specific.
2003, (6): 347-349.
Abstract:
OBJECTIVE To establish a new method to detect the two components of Psoralea corylifolia as a additive in cigarette and smoke. METHODS The SPME-GC-MS-SIM was used. RESULTS:The components(psoralen,isopsoralen)have been detected respectively. CONCLUSION The method has high sensitivity and fine repeatability. It can be applied to detect objects rapidly and simply.
OBJECTIVE To establish a new method to detect the two components of Psoralea corylifolia as a additive in cigarette and smoke. METHODS The SPME-GC-MS-SIM was used. RESULTS:The components(psoralen,isopsoralen)have been detected respectively. CONCLUSION The method has high sensitivity and fine repeatability. It can be applied to detect objects rapidly and simply.
2003, (6): 351-353.
Abstract:
OBJECTIVE An HPLC method was developed for determination of dl-Tetrahydropamatine in Yan-husuo. METHOD:The column was ODS Agilent zobax Extend C18(4.6×250mm,5μm),mobile phase was Meth-anol-0.1%. phosphoric acid(adjust pH 6.0 with Triethylamine)(55:45). Detection wavelength was set at 280nm. RESULT:Linearity range was 115-1376ng. The average recovery was 99.2%, RSD=1.5%(n=6). CONCLUSION The method is accurate and can be used for quality control of Yanhusuo.
OBJECTIVE An HPLC method was developed for determination of dl-Tetrahydropamatine in Yan-husuo. METHOD:The column was ODS Agilent zobax Extend C18(4.6×250mm,5μm),mobile phase was Meth-anol-0.1%. phosphoric acid(adjust pH 6.0 with Triethylamine)(55:45). Detection wavelength was set at 280nm. RESULT:Linearity range was 115-1376ng. The average recovery was 99.2%, RSD=1.5%(n=6). CONCLUSION The method is accurate and can be used for quality control of Yanhusuo.
2003, (6): 353-355.
Abstract:
OBJECTIVE To determine the content of ferulic acid in Fufang Danggui Diwan. METHODS HPLC was used. the mobile phase consisted of methanol - 1% glacial acetic acid(30:70). detection wavelengh was 323nm. RESULTS:The average recovery ratewas 98.90% with a RSD of 0.87%. CONCLUSION,The method is easy to operate,with accurate and reliable result. It is suitable for the quality control for Fufang Danggui Diwan.
OBJECTIVE To determine the content of ferulic acid in Fufang Danggui Diwan. METHODS HPLC was used. the mobile phase consisted of methanol - 1% glacial acetic acid(30:70). detection wavelengh was 323nm. RESULTS:The average recovery ratewas 98.90% with a RSD of 0.87%. CONCLUSION,The method is easy to operate,with accurate and reliable result. It is suitable for the quality control for Fufang Danggui Diwan.
2003, (6): 355-357.
Abstract:
OBJECTIVE To establish a GC method for the determination of organic solvents remaining. METHODS The methods was approved by high efficiency chlomatogram column of INNOWAX(30m×0.32mm×0.25μm),with a detector of FID using direct injection. RESULTS:There is no interfere of every component between ethanol,DMF,acetic acid inside standard and solven. The resolution and sensitivity were acceptable. The detection limit of the three components were 2.03μg/mL, 2.21μg/mL, 3.75μg/mL respectively. CONCLUSIONS This method is accurate to control the organic solvents remaining.
OBJECTIVE To establish a GC method for the determination of organic solvents remaining. METHODS The methods was approved by high efficiency chlomatogram column of INNOWAX(30m×0.32mm×0.25μm),with a detector of FID using direct injection. RESULTS:There is no interfere of every component between ethanol,DMF,acetic acid inside standard and solven. The resolution and sensitivity were acceptable. The detection limit of the three components were 2.03μg/mL, 2.21μg/mL, 3.75μg/mL respectively. CONCLUSIONS This method is accurate to control the organic solvents remaining.
2003, (6): 357-359.
Abstract:
OBJECTIVE To establish the fingerprint method for semen coicis. METHODS The Discovery® C18column with acetonitrile-ichloromethanol(59:41)as the mobile phase was used in HPLC-ELSD. The flow rate was 0.5mL/min and ELSD tube temperature is 70℃. The flow rate of Nitrogen is 1.2L/min. RESULTS:There are 7 mostly chromatogram in the fingerprint of semen coicis,the relative standard deviation(RSD)of relative retain time for reproducibility was not more than 0.3%,for precision was not more than 0.1%.the relative standand deviation(RSD)of relative peak area for reproducibility was not more than 1.8%,for precision was not more than 2.0%,and the fingerprint for semen coicis of different producing area is very stabilization. CONCLUSION The method is simple,accurate with a good reproducibility and can be used as a quantitative analysis method for semen coicis.
OBJECTIVE To establish the fingerprint method for semen coicis. METHODS The Discovery® C18column with acetonitrile-ichloromethanol(59:41)as the mobile phase was used in HPLC-ELSD. The flow rate was 0.5mL/min and ELSD tube temperature is 70℃. The flow rate of Nitrogen is 1.2L/min. RESULTS:There are 7 mostly chromatogram in the fingerprint of semen coicis,the relative standard deviation(RSD)of relative retain time for reproducibility was not more than 0.3%,for precision was not more than 0.1%.the relative standand deviation(RSD)of relative peak area for reproducibility was not more than 1.8%,for precision was not more than 2.0%,and the fingerprint for semen coicis of different producing area is very stabilization. CONCLUSION The method is simple,accurate with a good reproducibility and can be used as a quantitative analysis method for semen coicis.
2003, (6): 360-361.
Abstract:
OBJECTIVE To improve the judgement method of Chloragenic acid in Fufang Daqingye Heji. METHODS To change the eluant of ethyl acetate - methanol - water form(10:2:3)to(10:4:6)and change the turns by smoked the thin layer in ammonia first and then observe the fluresence under the ultraviolet rays lamp(365 nm)instead of the common turns of observation first,smoke second. They show the Same yellow spot, under the condition of 10 to 30 degrees centigrade and relative humidity 30 to 70 percent. RESULTS:The TLC spots is clear and is easy to check out.
OBJECTIVE To improve the judgement method of Chloragenic acid in Fufang Daqingye Heji. METHODS To change the eluant of ethyl acetate - methanol - water form(10:2:3)to(10:4:6)and change the turns by smoked the thin layer in ammonia first and then observe the fluresence under the ultraviolet rays lamp(365 nm)instead of the common turns of observation first,smoke second. They show the Same yellow spot, under the condition of 10 to 30 degrees centigrade and relative humidity 30 to 70 percent. RESULTS:The TLC spots is clear and is easy to check out.
2003, (6): 362-364.
Abstract:
OBJECTIVES:To establish the TLC method of Nubao capsules, and ensure the safety and effect of clinical application. METHODS Flos Carthami, Radix Angelicae Sinensls, Rhizoma Chuanxiong, Radix Paeoniae Alba, Pericarpium Citri Reticulutae were identified by TLC. RESULTS:Flos Carthanai,Radix Angelicae Sinensis, Rhizonm Chaunxiong,Radix Paeoniae Alba,Pericarpium Citri Reticulatae could be detected by TLC. This method was strong specificity and the blank test showed no interference. CONCLUSION The methods are simple, sensitve and accurate with good reproducibility. The methods may be used for quality control of Nubao capsules.
OBJECTIVES:To establish the TLC method of Nubao capsules, and ensure the safety and effect of clinical application. METHODS Flos Carthami, Radix Angelicae Sinensls, Rhizoma Chuanxiong, Radix Paeoniae Alba, Pericarpium Citri Reticulutae were identified by TLC. RESULTS:Flos Carthanai,Radix Angelicae Sinensis, Rhizonm Chaunxiong,Radix Paeoniae Alba,Pericarpium Citri Reticulatae could be detected by TLC. This method was strong specificity and the blank test showed no interference. CONCLUSION The methods are simple, sensitve and accurate with good reproducibility. The methods may be used for quality control of Nubao capsules.
2003, (6): 367-369.
Abstract:
OBJECTIVE Promethazine Hydrocloride and Chlordiazepoxide were determined by HPLC in Fu-fang Luotuma Pian I. METHODS Phenomenex - ODS3 Column(250×4. 60mm,5μm),the mobile phase consisted of a mixtur mixture of methanol-phosphate buffer(dissolved 2.64g NH4H2P04 in 1000mL water adjusted pH to 3.0 with H3PO4)(55:45)at a flow rate of 1.0 mL/min,detection was done at 250nm,the injection volume was 20μL. RESULTS:The method offered good linearity 5.1-60.8μg/mL for promethazine hydrocloride(r=1.0000), and 5.2-60.4μg/mL for chlordiazepoxide(r=0.9999).The average recovery rates were 99.5% and 101.2% respectively. CONCLUSION This method is accurate and reliable for the quality control of this compound preparation.
OBJECTIVE Promethazine Hydrocloride and Chlordiazepoxide were determined by HPLC in Fu-fang Luotuma Pian I. METHODS Phenomenex - ODS3 Column(250×4. 60mm,5μm),the mobile phase consisted of a mixtur mixture of methanol-phosphate buffer(dissolved 2.64g NH4H2P04 in 1000mL water adjusted pH to 3.0 with H3PO4)(55:45)at a flow rate of 1.0 mL/min,detection was done at 250nm,the injection volume was 20μL. RESULTS:The method offered good linearity 5.1-60.8μg/mL for promethazine hydrocloride(r=1.0000), and 5.2-60.4μg/mL for chlordiazepoxide(r=0.9999).The average recovery rates were 99.5% and 101.2% respectively. CONCLUSION This method is accurate and reliable for the quality control of this compound preparation.
2003, (6): 369-370.
Abstract:
OBJECTIVE To develop a method for the determination of ephedrine hydrochloride in kegan nasal drops by HPLC. METHODS The chromatographic condition included ODS column and the mobile phase consisting of 0.01 mol/L KH2PO4 solution-acetonitrile(40:60).The detection wavelengthwas at 215nm,flow rate at 1.0mL/min. RESULTS:The calibration curve was linear over the rage of 40-96μg/mL. The average recovery was 96.1%.The method precision(RSD%)was 1.2%(n=5).CONCLUSION The method was convenient and accurate for the quality control of the preparation.
OBJECTIVE To develop a method for the determination of ephedrine hydrochloride in kegan nasal drops by HPLC. METHODS The chromatographic condition included ODS column and the mobile phase consisting of 0.01 mol/L KH2PO4 solution-acetonitrile(40:60).The detection wavelengthwas at 215nm,flow rate at 1.0mL/min. RESULTS:The calibration curve was linear over the rage of 40-96μg/mL. The average recovery was 96.1%.The method precision(RSD%)was 1.2%(n=5).CONCLUSION The method was convenient and accurate for the quality control of the preparation.
2003, (6): 371-373.
Abstract:
OBJECTIVE Dissolution of sibutramine hydrochloride tablet was determinated by HPLC. The chromatography conditions were as follows:Column, Shimadzu VP-ODS; mobile phase:methol -0.05mol/L KH2PO4(adjusted to pH 3.0 with H3P04)(70:30);velocity of flow:1mL/min;detection wavelength:223nm. The linear ranges were 5.0-50.0μg/mL. The average recoveries were 100.6%.
OBJECTIVE Dissolution of sibutramine hydrochloride tablet was determinated by HPLC. The chromatography conditions were as follows:Column, Shimadzu VP-ODS; mobile phase:methol -0.05mol/L KH2PO4(adjusted to pH 3.0 with H3P04)(70:30);velocity of flow:1mL/min;detection wavelength:223nm. The linear ranges were 5.0-50.0μg/mL. The average recoveries were 100.6%.
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