Temazepam Tablets

Benzodiazepine.

Temazepam Tablets contain Temazepam.

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

95.0  to 105.0% of the stated amount.

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).

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.

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%).

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.

Temazepam Tablets should be protected from light.