Indoramin Tablets

Action and use

Alpha₁-adrenoceptor antagonist.

Definition

Indoramin Tablets contain Indoramin Hydrochloride. They are coated.

Content of indoramin, C₂₂H₂₅N₃O

95.0 to 105.0% of the stated amount.

Identification

Shake a quantity of the powdered tablets containing the equivalent of 0.1 g of indoramin with 25 mL of water for 5 minutes, filter (Whatman GF/C paper is suitable), make the filtrate alkaline with 2m sodium hydroxide and extract with 20 mL of dichloromethane. Wash the extracts with two 10 mL quantities of water, dry by shaking with anhydrous sodium sulfate and evaporate to dryness using a rotary evaporator. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of indoramin (RS 188).

TESTS

Related substances

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 1 volume of 18m ammonia, 20 volumes of absolute ethanol and 79 volumes of toluene as the mobile phase. Apply separately to the plate 10 µL of each of the following solutions. For solution (1) add 10 mL of ethanol (96%) to a quantity of the powdered tablets containing the equivalent of 0.1 g of indoramin, shake for 30 minutes and filter. For solution (2) dilute 1 volume of solution (1) to 200 volumes with ethanol (96%). For solution (3) dilute 1 volume of solution (2) to 5 volumes with ethanol (96%). After removal of the plate, allow it to dry in a current of warm air and examine it 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) (0.1%). Disregard any spot remaining on the line of application.

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 900 mL of 0.1m hydrochloric acid as the medium and rotate the paddle at 50 revolutions per minute. Withdraw a sample of 10 mL of the medium. Measure the absorbance of a layer of suitable thickness of the filtered sample, suitably diluted if necessary, at the maximum at 280 nm, Appendix II B. Calculate the total content of indoramin, C₂₂H₂₅N₃O, in the medium taking 186 as the value of A(1%, 1 cm) at the maximum at 280 nm.

Assay

Shake 10 whole tablets with 50 mL of 0.1m hydrochloric acid until the tablets have disintegrated, add 300 mL of ethanol (96%) and mix with the aid of ultrasound for 10 minutes, shaking occasionally. Add sufficient ethanol (96%) to produce 500 mL, filter (Whatman GF/C paper is suitable), dilute the filtrate with ethanol (96%) to contain 0.005% w/v of indoramin and measure the absorbance of the resulting solution at the maximum at 280 nm, Appendix II B. Calculate the content of C₂₂H₂₅N₃O taking 186 as the value of A(1%, 1 cm) at the maximum at 280 nm.

Storage

Indoramin Tablets should be protected from light.

Labelling

The quantity of active ingredient is stated in terms of the equivalent amount of indoramin.