复方蒿甲醚

Name: Compound Artemether Tables

Pinyin: Fufang Haojiami Pian

Reference Standard: Pharmacopoeia of the People’s Republic of China 2010 Volume 2. Content of Artemether,C16H26O5 90.0%~107.5% of the prescribed or stated amount.

Content of Lumefantrine,C30H32Cl3NO 93.0%~107.0% of the prescribed or stated amount.

Prescription:

Lumefantrine 120g

Artemether 20g

Excipient

Sufficient to produce 1000 pcs

Traits: yellow tablet.

Identification:

1.Take of Lumefantrine content determination of the solution, according to Test procedures of ultraviolet spectrophotometry testing procedures (JY-SOP-042-03),test the maximum absorption at 243nm,267nm,303nm and 339nm wavelength.

2.Grind a single tablet into powder, mix with acetone into solution. Take a few solution, add 3 ~ 4 drops of Citric acid acetic anhydride test solution, heat up in water bath after shaking, solution turns to purplish red.

3. Take of Artemether content determination of the sample and reference solution, according to TLC(Thin Layer Chromatography) Test Procedures (JY-SOP-070-03), sample and reference solution should have the same bluish violet spots and the same position.

Inspection:

1.Reducing arteannuim: Take of Artemether content determination of the solution for sample. Put 10mg reducing arteannuim into 10ml graduated flask, mix with trichloromethane. According to TLC Test Procedures (JY-SOP-070-03), take 50ul of the sample and reference solution, drop on the same H-silica gel board(add 0.3%CMC-Na),use cyclohexane- acetidin- glacial acetic

acid(40:20:2) as developer, airing after ascending development, spray with the

color-developer(solution of 0.25g paradimethylaminobenzaldehyde,3ml 85% phosphoric

acid,50ml glacial acetic acid and 20ml water),heat up for 15minutes at 105℃, the spots of the reducing arteannuim from the sample solution can not be deeper than the spots from the reference solution.

2. Disintegration time limited: It should be all disintegrated within 15 minutes (Test procedures of Disintegration time limit test (JY-SOP-072-03)).

3. Weight variation: Take 20pcs tablet, measuring the total weight precisely, calculate the average weight of every single tablet. Then calculate every single tablet’s weight precisely. Compare the average weight with actual weight, the amount of the over limit tablet must be no more than 2pcs,and neither of them should not weight double the limit. Limit should be strictly

up to the specification. (Test procedures of Weight variation and content uniformity testing

(JY-SOP-079-03)).

4. Friability: According to Test procedures of testing method for friability of tablets

(JY-SOP-075-03), weight loss must be less than 1% together with no fracture, crack and crashing tablets.

Microbial limit:

1. Bacterial population: No more than 1000 ORG/GM (Test procedures of microbial limit testing JY-SOP-052-03)

2. Mold and yeast: No more than 100ORG/GM (Test procedures of microbial limit testing

JY-SOP-052-03)

3. Escherichia coli: Can not be detected (Test procedures of microbial limit testing JY-SOP-052-03)

4. Mites: Can not be detected (Test procedures of mites testing JY-SOP-078-03)

Assay:

1. Lumefantrine: Take 10pcs tablet, weight and grind into powder. Weight appropriate amount contains 30mg Lumefantrine, mix with trichloromethane into solution with a 100ml graduated flask, then filtrate the solution. Abandon the initial filtrate, take 1ml subsequent filtrate, mix with trichloromethane in a 25ml graduated flask and shake. Use trichloromethane as blank, measure the absorptivity at 339nm wavelength according to Test procedures of ultraviolet spectrophotometry testing procedures (JY-SOP-042-03), then use 295( the coefficient of

C30H32Cl3NO) to calculate. Get the result after calculation.

2. Artemether:

Method I:Test of chromatographic condition and system flexibility of artemether according to test procedures of HPLC(high performance liquid chromatography) testing(JY-SOP-041-43).

Use octadecylsilane chemically bonded silica as filler, water-acetonitrile (45∶55) as mobile phase, testing wavelength is 210nm. theoretical plate number can not be less than 2000 calculate by peak value of artemether.

Assay method:Take appropriate amount, put into 10ml graduated flask, mix with mobile phase and shake, measure 20ul and add into liquid chromatograph, record the chromatogram.

Take appropriate amount of artemether reference substance, test with the same

method.Calculate according to the external standard method with peak area. Get the result after calculation.

Method II:

Prepare the solution of artemether reference substance:

Weight 20mg artemether reference substance, mix with appropriate amount a trichloromethane

in a 10ml graduated flask to make artemether reference substance into solution, dilute to the mark.

Prepare the solution of artemether sample:

Take 10pcs tablets,weight and grind into powder. Weight appropriate amount contains artemether 20mg mix with appropriate amount a trichloromethane in a 10ml graduated flask to make artemether into solution, dilute to the mark. Abandon the initial filtrate, take the subsequent filtrate.

Assay method: Test according to TLC Test Procedures (JY-SOP-070-03), take 50ul of the sample and reference solution, drop on the same H-silica gel board(add 0.3%CMC-Na),use cyclohexane-