Phenylephrine Injection

Alpha-adrenoceptor agonist.

Phenylephrine Injection is a sterile solution of Phenylephrine Hydrochloride in Water for Injections.

The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.

95.0 to 105.0% 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 add, if necessary, sufficient water to produce 1 mL and then add 0.05 mL of weak 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.

C. Yields reaction A characteristic of chlorides, Appendix VI.

pH, 4.5 to 6.5, Appendix V L.

Carry out the method for thin-layer chromatography, Appendix III A, using silica gel H as the coating substance and a mixture of 5 volumes of chloroform, 15 volumes of 10m ammonia and 80 volumes of propan-2-ol as the mobile phase. Apply separately to the plate 5 µL of each of the following solutions. For solution (1) evaporate a volume of the injection containing 20 mg of Phenylephrine Hydrochloride to dryness and dissolve the residue in 1 mL of methanol. For solution (2) dilute 1 volume of solution (1) to 200 volumes with methanol. For solution (3) dilute 1 volume of solution (2) to 2.5 volumes with methanol. Solution (4) contains 0.01% w/v of phenylephrine hydrochloride BPCRS in methanol. After removal of the plate, dry it in a current of cold air, spray with ninhydrin solution, heat at 100° to 105° for 10 minutes and examine in daylight. 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 two such spots are more intense than the spot in the chromatogram obtained with solution (3) (0.2%).

To a quantity containing 50 mg of Phenylephrine Hydrochloride add sufficient 0.5m sulfuric acid to produce 100 mL. Dilute 10 mL to 100 mL with 0.5m sulfuric acid and measure the absorbance of the resulting solution at the maximum at 273 nm, Appendix II B. Calculate the content of C₉H₁₃NO₂,HCl taking 90 as the value of A(1%, 1 cm) at the maximum at 273 nm.

Phenylephrine Injection should be protected from light.