富马酸替诺福韦酯--------印度药典

Solvent mixture. 80 volumes of buffer solution prepared by diluting 5.0 ml of triethylamine to 2000 ml with water and 20 volumes of methanol. Test solution. Shake 5 intact tablets with 100 ml ofthe solvent mixture and sonicate for 45 minutes. Dilute to 250 ml with the solvent mixture and filter. Further dilute to obtain 0.004 per cent w/v solution with the solvent mixture. lleference solution. A 0.004 per cent w/v solution of telmisartan RS in the solvent mixture.
Chromatographic system a stainless steel column l5cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5 /lm) (suc4 as InertsilODS-3), mobile phase: A. dissolve 0.5 g of potassium dihydrogen phosphate in 1000 ml of water; add 2 ml of triethylamine, adjusted to pH 3.2 with orthophosphoric acid, B. acetonitrile, a linear gradient programme using the conditions given below, flow rate. 1.8 ml per minute, spectrophotometer set at 298 nIn, injection volume. 20 Ill. Time (min.) Mobile phase A (per cent v/v) 78 80 70 Mobile phase B (per cent v/v) 22 20 30 40 40
NOTE - Prepare the solutions immediately before use. Test solution. Dissolve 100 mg of the substance under examination in 50 ml of methanol. Reference solution (a). A 0.2 per cent w/v solution of tenofovir disoproxil jitmarate RS in methanol. Reference solution (b). Dilute 1.0 ml ofreference solution (a) to 100.0 ml with methanol. Reference solution (c). Dissolve 10 mg ofthejUmaric acid in 50 ml of methanol.
o
6 7 15
60 60
40 20 78
25
26 35 40
Tenofovir Disoproxil Fumarate
60
80 22
Inject the reference solution. The test is not valid unless the theoretical plates is not less than 3000, tailing factor is not more than 2.0 and relative standard deviation for replicate injections is not more than 5.0 per cent. Inject the test solution and the reference solution. In the chromatogram obtained with the test solution the area of any secondary peak is not more than the area ofthe principal peak in the chromatogram obtained with the reference solution (0.5 per cent), the sum ofthe area of all the secondary peaks is not more than 4 times the area of the principal peak in the chromatogram obtained with reference solution (2.0 per cent). Ignore any peak with an area less than 0.1 times the area ofthe -principal peakinthe chromatogram obtained with the reference solution (0.05 per cent). Other tests. Comply with the tests stated under Tablets. Assay. Determine by liquid chromatography (2.4.14).
TELMISARTAN TABLETS
IP 2010
Solvent mixture. 80 volumes of buffer solution prepared by diluting 5.0 ml of triethylamine to 2000ml with water and 20 volumes of methanol. Test solution. Weigh and powder 20 tablets. Disperse a quantity ofpowder containing about 100 mg ofTelmisartan in 100.0 ml ofsolvent mixture, sonicate for 45 minutes and filter. Reference solution. A 0.0005 per cent w/v solution of telmisartan RS in the solvent mixture.
Chromatographic system - a stainless steel column 15 cm x 4.6 mm, packed with octadecylsilane bonded to porous silica (5 /lm) (such as Inertsil ODS-3), - mobile phase: a mixture of60 volumes ofbuffer solution prepared by dissolving 2.72 g ofpotassium dihydrogen phosphate in 1000 ml of water; add 2 ml of triethylamine and adjust the pH to 2.4 with orthophosphoric acid and 40 volumes of acetonitrile, flow rate. 1 ml per minute, - spectrophotometer set at 298 nIn, - injection volume. 20 Ill. Inject the reference solution. The test is not valid unless the theoretical plates is not less than 3000, the tailing factor is not more than 2.0 and the relative standard deviation for replicate injections is not more than 2.0 percent. Inject the test solution and the reference solution. Calculate the content of C33H30N40z in the tablets.
Байду номын сангаас
Tests
Related substances. Detennine by liquid chromatography (2.4.14).
Inject the test solution, reference solution (b) and reference solution (c). In the chromatogram obtained with the test solution, the area of any secondary peak is not more than the area of the peak in the chromatogram obtained with the reference solution (b) (1.0 per cent) and the sum of all the secondary peaks is not more than 2.5 times the' area of the peak in the chromatogram obtained with the reference solution (b) (2.5 per cent). Ignore any peak corresponding to the peak obtained in the chromatogram in the reference solution (c) and any peak having area less than 0.02 times the area of the principal peak in the chromatogram obtained with reference solution (b) (0.02 per cent). Fumaric Acid. 17.5 per cent to 19.0 percent. Detennine by liquid chromatography (2.4.14).
2188
IP 2010
TENOFOVIR DISOPROXIL FUMARATE
Identification
A. Detennine by infrared absorption spectrophotometry (2.4.6). Compare the spectrum with that obtained with tenofovir disoproxil jitmarate. RS or with the reference spectrum of tenofovir disoproxil fumarate.
B. In the Assay, the principal peak in the chromatogram obtained with the test solution corresponds to the peak in the chromatogram obtained with the reference solution.
,
HXGaaH
I
HaaG
H
Mol. Wt. 635.5 Tenofovir Disoproxil Fumarate salt ofbis(isopropyloxycarbonyloxymethyl ester of (R)-9-(2-phosphonomethoxypropyl)adenine with fumaric acid. Tenofovir Disoproxil Fumarate contain not less than 97.0 per cent and not more than 102. 0 per cent ofCI9H30N501OP,C4~04, c!ll~lll_at~~ on tl1eanb:ydr()us basis. Category. Antiviral. Dose. 300 mg daily. Description. A white to off- white crystalline powder.