Choline Theophyllinate Tablets

General Notices

Action and use

Non-selective phosphodiesterase inhibitor (xanthine); treatment of reversible airways obstruction.

Definition

Choline Theophyllinate Tablets contain Choline Theophyllinate. They are coated.

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

Content of choline theophyllinate, C12H21N5O3

95.0 to 105.0% of the stated amount.

Identification

A. Shake a quantity of the powdered tablets containing 0.1 g of Choline Theophyllinate with 20 mL of absolute ethanol for 10 minutes, filter and evaporate the filtrate to dryness. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of choline theophyllinate (RS 060).
B. The light absorption of the final solution obtained in the Assay, Appendix II B, exhibits a maximum at 275 nm.

Tests

Related substances

Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.

(1) Shake a quantity of the powdered tablets containing 0.1 g of Choline Theophyllinate with 10 mL of ethanol (96%) for 10 minutes and filter.
(2) Dilute 1 volume of solution (1) to 100 volumes with ethanol (96%).
chromatographic conditions
(a) Use as the coating silica gel HF254.
(b) Use the mobile phase as described below.
(c) Apply 5 µL of each solution.
(d) Develop the plate to 15 cm.
(e) After removal of the plate, dry in air and examine under ultraviolet light (254 nm).
mobile phase

5 volumes of ethanol (96%) and 95 volumes of chloroform.

limits

Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2).

Assay

Weigh and powder 20 tablets. To a quantity of the powder containing 0.1 g of Choline Theophyllinate add 500 mL of water shake vigorously for 2 minutes, dilute to 1000 mL with water, mix and filter. To 10 mL of the filtrate add 10 mL of 0.1m sodium hydroxide and dilute to 100 mL with water. Measure the absorbance of the resulting solution at the maximum at 275 nm, Appendix II B. Calculate the content of C12H21N5O3 taking 415 as the value of A(1%, 1 cm) at the maximum at 275 nm.

Storage

Choline Theophyllinate Tablets should be protected from light.