High Quality USP/EP/BP GMP DMF FDA Tramadol Capsules CAS 27203-92-5 Producer Iin store

Tramadol Capsules 

Opioid receptor agonist; noradrenaline reuptake inhibitor; analgesic.

Definition

Tramadol Capsules contain Tramadol Hydrochloride.

The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of tramadol hydrochloride, C16H25NO2,HCl

A.  Carry out the method for thin-layer chromatography, Appendix  III  A, using a TLC silica gel  F254 plate (Merck plates are suitable) and a mixture of 1  volume of anhydrous formic acid, 50  volumes of acetone and 50  volumes of methanol as the mobile phase. Apply separately to the plate 10  µl of each of the following solutions. For solution  (1) add 25  ml of methanol to a quantity of the contents of the capsules containing 50  mg of Tramadol Hydrochloride, shake for 10  minutes and filter through a glass-fibre filter (Whatman  GF/A is suitable). Solution  (2) contains 0.2%  w/v of tramadol hydrochloride BPCRS in methanol. After removal of the plate, allow it to dry in air, expose to iodine vapour until spots appear and examine in daylight. The principal spot in the chromatogram obtained with solution  (1) corresponds to that in the chromatogram obtained with solution  (2).

B.  In the Assay, the retention time of the principal peak in the chromatogram obtained with solution  (1) corresponds to that of the principal peak in the chromatogram obtained with solution  (2).

Tests

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution  (1), mix with the aid of ultrasound, a quantity of the contents of the capsules containing 0.5  g of Tramadol Hydrochloride with 80  ml of the mobile phase, cool, add sufficient mobile phase to produce 100  ml and filter through a glass-fibre filter (Whatman GF/A is suitable). For solution (2) dilute  2 volumes of solution (1) to 100  volumes with the mobile phase and further dilute 1 volume to 10  volumes with the mobile phase. Solution (3) contains 0.0015%  w/v of tramadol impurity  A  EPCRS in the mobile phase. Solution (4) contains 0.0015%  w/v each of tramadol hydrochloride  BPCRS and tramadol impurity  A EPCRS in the mobile phase.

The chromatographic procedure may be carried out using (a) a stainless steel column (25  cm  ×  4.6 mm) packed with octadecylsilyl silica gel for chromatography (5 µm) (Waters Symmetry C18 is suitable), (b) as the mobile phase with a flow rate of 1.0  ml per minute a mixture of 1  volume of trifluoroacetic acid, 30  volumes of acetonitrile and 69  volumes of water and (c) a detection wavelength of 271  nm.

The test is not valid unless, in the chromatogram obtained with solution  (4), the resolution factor between the two principal peaks is at least 3.0.

For solution (1) allow the chromatography to proceed for four times the retention time of the principal peak. In the chromatogram obtained with solution (1) the area of any peak corresponding to tramadol impurity A is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (0.3%), the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%) and the sum of the areas of any secondary peaks is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1%).

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution  (1),  mix with the aid of ultrasound, a quantity of the mixed contents of 20  capsules containing 50  mg of Tramadol Hydrochloride with 150  ml of the mobile phase, cool, add sufficient mobile phase to produce 200  ml and filter through a glass-fibre filter (Whatman  GF/A is suitable). Solution (2) contains 0.025%  w/v of tramadol hydrochloride BPCRS in the mobile phase. Solution (3) 0.0015% w/v each of tramadol hydrochloride BPCRS and tramadol impurity A EPCRS in the mobile phase.

The chromatographic procedure described under Related substances may be used.

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the two principal peaks is at least 3.0.

Calculate the content of C16H25NO2,HCl using the declared content of C16H25NO2,HCl in tramadol hydrochloride BPCRS.