Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Prostaglandin (PGF2α) analogue.
DEFINITION
Cloprostenol Injection is a sterile solution of Cloprostenol Sodium in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of cloprostenol, C22H29ClO6
90.0 to 110.0% of the stated amount.
IDENTIFICATION
In the Assay, the chromatogram obtained with solution (1) shows a peak with the same retention time as the peak due to cloprostenol in the chromatogram obtained with solution (2).
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Dilute the injection, if necessary, in absolute ethanol to contain the equivalent of 0.009% w/v of cloprostenol.
(2) 0.00018% w/v of cloprostenol sodium BPCRS in absolute ethanol.
(3) Dissolve 5 mg of hydrocortisone acetate BPCRS and 2.5 mg of cloprostenol sodium BPCRS in absolute ethanol and dilute to 10 mL with the mobile phase.
CHROMATOGRAPHIC CONDITIONS
(a) Use a stainless steel column (25 cm × 5 mm) packed with base-deactivated octadecylsilyl silica gel for chromatography (Waters Symmetry ODS is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1.8 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 220 nm.
(f) Inject 20 µL of each solution.
(g) For solutions (1) and (2) allow the chromatography to proceed for 1.5 times the retention time of the principal peak.
MOBILE PHASE
270 volumes of acetonitrile and 730 volumes of a solution containing 0.24% w/v of sodium dihydrogen orthophosphate the pH of which has been adjusted to 2.5 with orthophosphoric acid.
SYSTEM SUITABILITY
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peak due to hydrocortisone acetate (retention time about 25 minutes) and that of cloprostenol (retention time about 35 minutes) is at least 6.
LIMITS
In the chromatogram obtained with solution (1) the sum of the areas of any secondary peaks is not more than 1.25 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%).
ASSAY
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Dilute the injection, if necessary, in absolute ethanol to contain the equivalent of 0.009% w/v of cloprostenol.
(2) 0.009% w/v of cloprostenol sodium BPCRS in absolute ethanol.
(3) Dissolve 5 mg of hydrocortisone acetate BPCRS and 2.5 mg of cloprostenol sodium BPCRS in absolute ethanol and dilute to 10 mL with the mobile phase.
CHROMATOGRAPHIC CONDITIONS
The chromatographic conditions described under Related substances may be used.
SYSTEM SUITABILITY
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peak due to hydrocortisone acetate (retention time about 25 minutes) and that of cloprostenol (retention time about 35 minutes) is at least 6.
DETERMINATION OF CONTENT
Calculate the content of C22H29ClO6 in the injection using the declared content of C22H29ClO6 in cloprostenol sodium BPCRS.
STORAGE
Cloprostenol Sodium Injection should be protected from light.
LABELLING
The quantity of active ingredient is stated in terms of the equivalent amount of cloprostenol in a suitable dose-volume.
