Temazepam Tablets

General Notices

Action and use

Benzodiazepine.

Definition

Temazepam Tablets contain Temazepam.

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

Content of temazepam, C16H13ClN2O2

95.0 to 105.0% of the stated amount.

Identification

A. The light absorption, Appendix II B, in the range 210 to 400 nm of the final solution obtained in the Assay exhibits two maxima at 230 nm and at 315 nm and a shoulder at 250 nm.
B. Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable) and a mixture of 10 volumes of diethylamine and 90 volumes of ether as the mobile phase. Apply separately to the plate 5 µl of each of the following solutions. For solution (1) shake a quantity of the powdered tablets containing 20 mg of Temazepam for 5 minutes with 20 ml of methanol and filter. Solution (2) contains 0.10% w/v of temazepam BPCRS in methanol. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). The chromatogram obtained with solution (1) exhibits a spot which corresponds to the spot in the chromatogram obtained with solution (2).

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1, using Apparatus 2. Use as the medium 900 ml of 0.1m hydrochloric acid and rotate the paddle at 50 revolutions per minute. Measure the absorbance of a layer of suitable thickness of the filtered sample, suitably diluted if necessary, with 0.1m hydrochloric acid, at the maximum at 237 nm, Appendix II B, using 0.1m hydrochloric acid in the reference cell. Measure the absorbance of a suitable solution of temazepam BPCRS in the dissolution medium and calculate the total content of temazepam, C16H13ClN2O2, in the medium from the absorbances obtained and from the declared content of C16H13ClN2O2 in temazepam BPCRS.

Related substances

Carry out the test protected from light. Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel F254 precoated plate (Merck silica gel 60 F254 plates are suitable) and a mixture of 2 volumes of methanol and 98 volumes of dichloromethane as the mobile phase. Apply separately to the plate 20 µl of each of the following solutions, prepared immediately before use, in low-actinic glassware. For solution (1) shake a quantity of the powdered tablets containing 50 mg of Temazepam for 10 minutes with 5 ml of a mixture of equal volumes of dichloromethane and methanol and filter. For solution (2) dilute 1 volume of solution (1) to 200 volumes with the same solvent mixture. For solution (3) dilute 2 volumes of solution (2) to 5 volumes with the same solvent mixture. After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 nm). Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (2) (0.5%) and not more than one such spot is more intense than the spot in the chromatogram obtained with solution (3) (0.2%).

Assay

Carry out the following procedure protected from light. Weigh and powder 20 tablets. Shake a quantity of the powdered tablets containing 20 mg of Temazepam with 75 ml of methanol for 20 minutes, dilute to 100 ml with the same solvent and filter. Dilute 10 ml of the resulting filtrate to 250 ml with methanol and measure the absorbance of the resulting solution at the maximum at about 230 nm, Appendix II B. Calculate the content of C16H13ClN2O2 in the tablets from the absorbance obtained using a 0.0008% w/v solution of temazepam BPCRS in methanol and using the declared content of C16H13ClN2O2 in temazepam BPCRS.

Storage

Temazepam Tablets should be protected from light.