- British Pharmacopoeia Volume III
- Formulated Preparations: Specific Monographs
Bupivacaine and Diamorphine Injection |
note: Bupivacaine and Diamorphine Injection is not currently licensed in the United Kingdom.
Spinal anaesthetic; analgesic.
Bupivacaine and Diamorphine Injection is a sterile solution of Bupivacaine Hydrochloride and Diamorphine Hydrochloride, made isotonic with Sodium Chloride, in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations, the requirements stated under Unlicensed Medicines and with the following requirements.
95.0 to 105.0% of the stated amount.
90.0 to 110.0% of the stated amount.
A. In the Assay, the retention times of the two principal peaks in the chromatogram obtained with solution (1) correspond to those in the chromatogram obtained with solution (4).
B. Yields reaction A characteristic of chlorides, Appendix VI.
pH, 4.0 to 5.0, Appendix V L.
Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a 0.9% w/v solution of sodium chloride.
(1) Dilute a quantity of the injection to produce a solution containing the equivalent of 0.04% w/v of anhydrous bupivacaine hydrochloride.
(2) 1% w/v of bupivacaine hydrochloride BPCRS.
(3) 0.03% w/v of diamorphine hydrochloride BPCRS.
(4) Mix 1 volume of solution (2) and 1 volume of solution (3) and add sufficient of a 0.9% w/v solution of sodium chloride to produce 25 volumes.
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS2 is suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use a column temperature of 30°.
(e) Use a detection wavelength of 260 nm.
(f) Inject 10 µL of each solution.
When the chromatograms are recorded under the prescribed conditions, the retention time of diamorphine hydrochloride is about 3.5 minutes and the retention time of bupivacaine hydrochloride is about 5.5 minutes.
45 volumes of acetonitrile and 55 volumes of 0.01m sodium heptanesulfonate, containing 0.0075m N,N-dimethyloctylamine, which has been adjusted to pH 3.0 with orthophosphoric acid.
Calculate the content of C18H28N2O,HCl and of C21H23NO5,HCl,H2O in the injection using the declared content of C18H28N2O,HCl in bupivacaine hydrochloride BPCRS and the declared content of C21H23NO5,HCl,H2O in diamorphine hydrochloride BPCRS.
Bupivacaine and Diamorphine Injection should be protected from light.
The label states that the injection is intended for epidural administration. The quantity of Bupivacaine Hydrochloride is stated in terms of the equivalent amount of anhydrous bupivacaine hydrochloride.