Rosuvastatin IP Monograph

Rosuvastatin Calcium contains not less than 98.
0 per cent and not more than

102.0 per cent of (C22H27FN306S)2.Ca. calculated on the anhydrous basis.
Category. Antihyperlipidaemic.
Description. An off- white to creamish white crystalline powder.
Identification
A. Determine by infrared absorption spectrophotometry(2.4.6).
Compare the spectrum with that obtained with Rosuvastatin calcium RS. ..
B. Dissolve 20 mg in 25 ml of methanol, add 2 drops of methyl red indicator
neutralise with 6 M ammonium hydroxide. Add 3 M hydrochloric acid until the
solution is acidic to the indicator. Add ammonium oxalate solution, a white
precipitate is obtained.
Tests
Related substances. Determine by liquid chromatography (2.4.14).
Test solution. Dissolve 50 mg of the substance under examination in 100 ml of
the mobile phase.
Reference solution (a). A 0.05 per cent w/v solution of rosuvastatin calcium
RS in the mobile phase.
Reference solution (b). Dilute 1ml of reference solution (a) to 100 ml with
mobile phase.
Chromatographic system
- a stainless steel column 25 cm x 4.6 mm packed with octadecylsilane bonded
to porous silica (5 ~m),
- mobile phase: a mixture of 50 volumes of 0.2 per cent w/v acetic acid in
water, 25 volumes of acetonitrile and 25 volumes of methanol,
flow rate. 1ml per minute,
spectrophotometer set at 248 nm,
injection volume. 20 ~l.
Inject reference solution (a). The test is not valid unless the tailing factor is not
more than 2.0 and the column efficiency in not less than 2000 theoretical
plates.
Inject the test solution and reference solution (b). In the chromatogram
obtained with the test solution, the area of any secondary peak is not more than
0.5 times the area of the peak in the chromatogram obtained with reference
solution (b) (0.5 per cent) and the sum of areas of all the secondary peaks
is not more than twice the area of the peak in the chromatogram obtained with
the reference solution (b) (2.0 per cent).
Water (2.3.43). Not more than 8.0 per cent, determined on 0.3 g.
Assay. Determine by liquid chromatography (2.4.14).
Test solution. Dissolve 50 mg of the substance under examination in 100.0 ml
of mobile phase. Dilute 5.0 ml of the solution to 25.0 ml with mobile phase,
mix and filter.
Reference solution. A 0.05 per cent w/v of rosuvastatin calcium RS in mobile
phase. Dilute 5.0 ml of the solution to 25.0 ml with mobile phase.
- a stainless steel column 25 cm x 4.6 mm packed with
octadecylsilane bonded to porous silica (5 ~m),
- mobile phase: a mixture of 50 volumes of 0.2 per cent
acetic acid in water, 25 volumes of acetQn.itrile and
25 volumes of methanol, filter and degas.
flow rate. 1ml per minute,
spectrophotometer set at 248 nm,
injection volume. 20 ~l.
Inject the reference solution. The test is not valid unless the relative standard
deviation for replicate injections is not more than 2.0 per cent.
Inject the test solution and the reference solution.
Calculate the content of (C22H27FN)06S)2.Ca.
Storage. Store protected from light and moisture.
Rosuvastatin Calcium Tablets

Rosuvastatin Tablets contain not less than 90.0 per cent and not more than
110.0 per cent of the stated amount of rosuvastatin, C44Hs4F2N6012S2.
Usual strengths. 5 mg; 10 mg; 20 mg.
Identification
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.
Tests
Dissolution (2.5.2).
Apparatus No.1,
Medium. 900 ml of phosphate buffer pH 6.8,
Speed and time. 50 rpm and 30 minutes.
Withdraw a suitable volume of the medium and filter.
Determine by liquid chromatography (2.4.14).
Test solution. The filtrate obtained as given above.
Reference solution. A 0.05 per cent w/v solution of rosuvastatin calcium RS in
the mobile phase. Dilute 2 ml of the solution to 100 ml with Dissolution
medium.
Chromatographic system as described under Assay.
Calculate the content ofC44Hs4F2N6012S2.
D. Not less than 70 per cent of the stated amount of
C44Hs4F2N6012S2.
Uniformity of content. Comply with the tests stated under
Tablets.
Determine by liquid chromatography (2.4.14), as described under Assay.
Test solution. Disperse one tablet in 100ml of the mobile phase.
Dilute 5 ml of the solution to 10 ml with mobile phase and filter.
Related substances. Determine by liquid chromatography
(2.4.14).
Test solution. Weigh and powder 20 tablets. Weigh accurately a quantity of
powdered tablet containing 25 mg of Rosuvastatin, disperse in 50 ml of mobile
phase and filter.
Reference solution (a). A 0.05 per cent w/v solution of rosuvastatin calcium
RS in the mobile phase.
Reference solution (b). Dilute 1 ml of reference solution (a) to
100 ml with mobile phase.
Chromatographic system as described under Assay.
Inject reference solution (a). The test is not valid unless the tailing factor is not
more than 2.0 and the column efficiency in not less than 2000 theoretical
plates.
Inject the test solution and reference solution (b). In the chromatogram
obtained with the test solution, the area of any secondary peak is not more than
1.5 times the area of the peak in the chromatogram obtained with reference
solution (b)
(1.5 per cent) and the sum of areas of all the secondary peaks is not more than
3.0 times the area of the peak in the chromatogram obtained with the reference
solution (b) (3.0 per cent).
Other tests. Comply with the tests stated under Tablets.
Assay. Determine by liquid chromatography (2.4.14).
Test solution. Weigh and powder 20 tablets. Weigh accurately a quantity of
powdered tablet containing 25 mg of Rosuvastatin, disperse in 100.0 ml of
mobile phase. Dilute 5.0 ml of the solution to 25.0 ml with mobile phase and
filter.
Reference solution. A 0.025 per cent w/v solution of rosuvastatin calcium RS
in mobile phase. Dilute 5.0 ml of the solution to 25.0 ml with mobile phase.
- a stainless steel column 25 cm x 4.6 mm packed with
octadecylsilane bonded to porous silica (5 Ilm),
- column temperature 30°,
- mobile phase: a mixture of 585 volumes of a buffer solution prepared by
dissolving 1.54 g of ammonium acetate in 900 ml water, adjust pH to 4.0 with
glacial acetic acid and dilute to 1000 ml with water, 360 volumes of
acetonitrile and 50 volumes of tetrahydrojitrane,
- flow rate. 1.5 ml per minute,
- spectrophotometer set at 248 nm,
- injection volume. 20 Ill.
Inject the reference solution. The test is not valid unless thecolumn efficiency
is not less than 2000 theoretical plates, the tailing factor is not more than 2.0
and the relative standard deviation for replicate injections is not more than 2.0
per cent.
Inject the test solution and the reference solution.
Calculate the content ofC44Hs4F2N6012S2.
Storage. Store protected from light and moisture.
Labelling. The label states the strength in terms of the equivalent amount of
Rosuvastatin.

Rosuvastatin IP Monograph

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Rosuvastatin IP Monograph

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Rosuvastatin Calcium contains not less than 98.

0 per cent and not more than

Storage. Store protected from light and moisture.

Rosuvastatin Calcium Tablets

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