Adrenaline Eye Drops / Epinephrine Eye Drops

Neutral Adrenaline Eye Drops

 

Neutral Epinephrine Eye Drops

 

Definition

 

Adrenaline Eye Drops are a sterile solution of Adrenaline in Purified Water.

 

The eye drops comply with the requirements stated under Eye Preparations and with the following requirements.

 

Content of adrenaline, C9H13NO3

 

95.0 to 110.0% of the stated amount.

 

Identification

 

A.    In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (2) is the same as that of the principal peak in the chromatogram obtained with solution (1).

 

B.    To 1 ml of a dilution of the eye drops containing 0.1% w/v of Adrenaline adjusted, if necessary, to a neutral or slightly acidic pH add, drop wise, a 0.25% w/v solution of iron (III) chloride hexahydrate until a green colour is produced. On the gradual addition of sodium hydrogen carbonate solution, the solution changes first to blue and then to red.

 

C.    To 1 ml of a dilution of the eye drops containing 0.1% w/v of Adrenaline add 2 ml of a 10% w/v solution of disodium hydrogen orthophosphate and sufficient iodinated potassium iodide solution to produce a brown colour. Remove excess iodine by adding 0.2M sodium thiosulphate drop wise. A red colour is produced.

 

Acidity or alkalinity

 

pH, 5.5 to 7.6, Appendix V L.

 

Noradrenaline

 

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.0018% w/v of noradrenaline acid tartrate in the mobile phase. For solution (2) dilute the eye drops with the mobile phase to produce a solution containing 0.10% w/v of Adrenaline. Solution (3) contains 0.0018% w/v of noradrenaline acid tartrate and 0.0018% w/v of adrenaline acid tartrate BPCRS in the mobile phase.

 

The chromatographic procedure may be carried out using (a) a stainless steel column (10 cm 4.6 mm) packed with stationary phase C (5 µm) (Nucleosil C18 is suitable), (b) as the mobile phase with a flow rate of 2 ml per minute a solution containing 4.0 g of tetramethylammonium hydrogen sulphate, 1.1 g of sodium heptanesulphonate and 2 ml of 0.1M disodium edetate in a mixture of 950 ml of water  and 50 ml of methanol , the pH of the mixture being adjusted to 3.5 with 1M sodium hydroxide, and (c) a detection wavelength of 205 nm.

 

The test is not valid unless the resolution factor  between the two principal peaks in the chromatogram obtained with solution (3) is at least 2.0.

 

In the chromatogram obtained with solution (2) the area of any peak corresponding to noradrenaline is not greater than the area of the principal peak in the chromatogram obtained with solution (1) (1%).

 

Assay

 

Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.2% w/v of adrenaline acid tartrate BPCRS in the mobile phase. For solution (2) dilute the eye drops with sufficient mobile phase to produce a solution containing 0.1% w/v of Adrenaline. Solution (3) contains 0.2% w/v of adrenaline acid tartrate BPCRS and 0.2% w/v of noradrenaline acid tartrate in the mobile phase.

 

The chromatographic procedure may be carried out using (a) a stainless steel column (10 cm 4.6 mm) packed with stationary phase C (5 µm) (Nucleosil C18 is suitable), (b) as the mobile phase with a flow rate of 2 ml per minute, a solution prepared by adding 4.0 g of tetra-methylammonium hydrogen sulphate, 1.1 g of sodium heptanesulphonate and 2 ml of 0.1M disodium edetate to a mixture of 950 ml of water  and 50 ml of methanol , the pH of the mixture being adjusted to 3.5 with 1M sodium hydroxide and (c) a detection wavelength of 205 nm.

 

The test is not valid unless the resolution factor  between the two principal peaks in the chromatogram obtained with solution (3) is at least 2.0.

 

Calculate the content of C9H13NO3 in the eye drops using the declared content of C9H13NO3 in adrenaline acid tartrate BPCRS.

 

Storage

 

Adrenaline Eye Drops should be protected from light.