Colecalciferol Tablets

General Notices

Action and use

Vitamin D analogue (Vitamin D3).

Definition

Colecalciferol Tablets contain Colecalciferol.

The tablets comply with the requirements stated under Tablets and with the following requirements.

Content of colecalciferol, C27H44O

90.0 to 125.0% of the stated amount.

Identification

A. In the test for Uniformity of content, the chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).
B. Extract one tablet, in powder, with 5 mL of ethanol-free chloroform, filter and to 1 mL of the filtrate add 9 mL of antimony trichloride solution. A brownish red colour is produced.

Tests

Uniformity of content

Tablets containing less than 2 mg and/or less than 2% w/w of Colecalciferol comply with the requirements stated under Tablets using the following method of analysis. Carry out the following procedure in subdued light and in low-actinic glassware. Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1) Disperse one tablet in 2 mL of water with the aid of ultrasound. Add 6 mL of dimethyl sulfoxide, shake with 50 mL of hexane for 30 minutes, centrifuge and retain the hexane layer. Add sufficient hexane, if necessary, to produce a solution expected to contain 0.00004% w/v of Colecalciferol.
(2) 0.00004% w/v of colecalciferol BPCRS in hexane.
(3) Dilute 1.0 mL of colecalciferol for system suitability EPCRS to 5.0 mL with hexane. Heat in a water-bath at 90 ° under a reflux condenser for 45 minutes and cool (formation of precolecalciferol).
chromatographic conditions
(a) Use a stainless steel column (20 cm × 4.6 mm) packed with silica gel for chromatography (5 µm) (Partisil is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 2 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 254 nm.
(f) Inject 50 µL of each solution.
mobile phase

8 volumes of pentan-1-ol and 992 volumes of hexane.

When the chromatograms are recorded under the prescribed conditions, approximate retention times relative to colecalciferol are 0.4 for precolecalciferol and 0.5 for trans-colecalciferol.

system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks corresponding to precolecalciferol and trans-colecalciferol is at least 1.0. If necessary, adjust the proportions of the constituents and the flow rate of the mobile phase to obtain this resolution.

determination of content

Calculate the content of colecalciferol, C27H44O, in each tablet using the declared content of C27H44O in colecalciferol BPCRS.

Assay

For tablets containing less than 2 mg and/or 2% w/w of colecalciferolUse the average of the 10 individual results obtained in the test for Uniformity of content.

For tablets containing 2 mg or more, or 2% w/w or more of colecalciferolCarry out the method for liquid chromatography, Appendix III D, using the following solutions. Carry out the following procedure in subdued light and in low-actinic glassware.

(1) Weigh and powder 20 tablets. Shake a quantity of tablets containing 100 micrograms of Colecalciferol with 30 mL of dimethyl sulfoxide, add 150 mL of hexane and shake for a further 30 minutes, add sufficient hexane to produce 250 mL, centrifuge and use the supernatant liquid.
(2) 0.00004% w/v of colecalciferol BPCRS in hexane.
(3) Dilute 1.0 mL of colecalciferol for system suitability EPCRS to 5.0 mL with hexane. Heat in a water-bath at 90 ° under a reflux condenser for 45 minutes and cool (formation of precolecalciferol).
chromatographic conditions

The chromatographic procedure described under Uniformity of content may be used

When the chromatogram is recorded under the prescribed conditions, approximate retention times relative to colecalciferol are 0.4 for precolecalciferol and 0.5 for trans-colecalciferol.

system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks corresponding to precolecalciferol and trans-colecalciferol is at least 1.0.

determination of content

Calculate the content of colecalciferol, C27H44O, in the tablets using the declared content of C27H44O in colecalciferol BPCRS.

STORAGE

Colecalciferol tablets should be protected from light and moisture.

Labelling

The label states the equivalent number of IU (units) of antirachitic activity (vitamin D) per tablet.

Each µg of Colecalciferol is equivalent to 40 IU of antirachitic activity (vitamin D).