Phenylephrine Eye Drops

Alpha-adrenoceptor agonist.

Phenylephrine Eye Drops are a sterile solution of Phenylephrine Hydrochloride in Purified Water.

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

90.0 to 110.0% of the stated amount.

A. In the test for Related substances, the principal spot in the chromatogram obtained with solution (2) corresponds to that in the chromatogram obtained with solution (4).

B. To a volume containing 10 mg of Phenylephrine Hydrochloride diluted with water if necessary to produce 1 mL add 0.05 mL of copper sulfate solution and 1 mL of 5m sodium hydroxide; a violet colour is produced. Add 1 mL of ether and shake; the ether layer remains colourless.

pH, 3.0 to 7.5, Appendix V L.

Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.

(1) Dilute the eye drops with sufficient methanol to give a solution containing 2% w/v of Phenylephrine Hydrochloride.

(2) Dilute 1 volume of solution (1) to 40 volumes with methanol.

(3) Dilute 1 volume of solution (1) to 100 volumes with methanol.

(4) 0.05% w/v of phenylephrine hydrochloride BPCRS in methanol.

(a) Use as the coating silica gel H.

(b) Use the mobile phase as described below.

(c) Apply 5 µL of each solution.

(d) Develop the plate to 15 cm.

(e) After removal of the plate, dry it in a current of cold air, spray with ninhydrin solution, heat at 100° to 105° for 5 to 10 minutes and examine in daylight.

5 volumes of chloroform, 15 volumes of 10m ammonia and 80 volumes of propan-2-ol.

Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the spot in the chromatogram obtained with solution (3) (1%).

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1) Dilute the eye drops with sufficient water to give a solution containing 0.1% w/v of Phenylephrine Hydrochloride.

(2) 0.1% w/v of phenylephrine hydrochloride BPCRS in water.

(a) Use a stainless steel column (15 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Hypersil C18 is suitable).

(b) Use isocratic elution and the mobile phase described below.

(c) Use a flow rate of 1.5 mL per minute.

(d) Use an ambient column temperature.

(e) Use a detection wavelength of 273 nm.

(f) Inject 20 µL of each solution.

0.10% w/v sodium heptanesulfonate in a mixture of 2 volumes of glacial acetic acid, 400 volumes of methanol and 600 volumes of water.

Calculate the content of C₉H₁₃NO₂,HCl using the declared content of C₉H₁₃NO₂,HCl in phenylephrine hydrochloride BPCRS.

Phenylephrine Eye Drops should be protected from light.