Edition: BP 2025 (Ph. Eur. 11.6 update)
Action and use
Phosphodiesterase inhibitor; smooth muscle relaxant.
DEFINITION
Papaverine Injection is a sterile solution of Papaverine Hydrochloride in Water for Injections.
The injection complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of papaverine hydrochloride, C20H21NO4, HCl
95.0 to 105.0% of the stated amount.
IDENTIFICATION
A. To a volume of the injection containing 60 mg of Papaverine Hydrochloride add 2 mL of ethanol (96%), evaporate to dryness on a steam bath with the aid of a stream of nitrogen and dry the residue at 105° for 2 hours. The infrared absorption spectrum, Appendix II A, is concordant with the reference spectrum of papaverine hydrochloride (RS 415).
B. Yields reaction A characteristic of chlorides, Appendix VI.
TESTS
Acidity
pH, 2.0 to 4.0, Appendix V L.
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) dilute a volume of the injection, if necessary, with methanol (50%) to produce a solution containing 0.06% w/v of Papaverine Hydrochloride. For solution (2) dilute 1 volume of solution (1) to 100 volumes with methanol (50%).Solution (3) contains 0.0005% w/v of papaverine hydrochloride BPCRS and 0.005% w/v of noscapine in the mobile phase.
The chromatographic procedure may be carried out using (a) a stainless steel column (25 cm × 4.6 mm) packed with endcapped octadecylsilyl silica gel for chromatography (5 µm) (Phenomenex Luna C(18)2 is suitable), (b) as the mobile phase with a flow rate of 1 mL per minute a mixture prepared by adding 700 mL of methanol containing 2.22 g of dioctyl sodium sulfosuccinate to 100 mL of water containing 1.36 g of sodium acetate, diluting to 1 litre with water and adjusting the pH to 5.5 with glacial acetic acid and (c) a detection wavelength of 250 nm.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to papaverine hydrochloride and noscapine is at least 3.0.
In the chromatogram obtained with solution (1), the sum of the areas of any secondary peaks is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1.0%).
ASSAY
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Solution (1) contains 0.0045% w/v of papaverine hydrochloride BPCRS in methanol (50%). For solution (2) dilute a volume of the injection, if necessary, with methanol (50%) to produce a solution containing 0.0045% w/v of Papaverine Hydrochloride.
The chromatographic method described under Related substances may be used.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to papaverine hydrochloride and noscapine is at least 3.0.
Calculate the content of C20H21NO4,HCl in the injection using the declared content of C20H21NO4,HCl in papaverine hydrochloride BPCRS.
STORAGE
Papaverine Injection should be protected from light.
