Shanghai Harvest Pharmaceutical Co., Ltd

Objective: To investigate the compatibility stability of caffeine citrate injection with three commonly used injections.Methods: The caffeine citrate injection was mixed with 5% glucose injection, 0.9% sodium chloride injection or 10% calcium gluconate injection, resp. and the mixtures were kept at room temperatureTheir properties, pH value, osmolality, and insoluble particles were investigated at 0 min, 10 min, 30 min, and 24 h after mixture, resp. and the contents of the related substances, caffeine and 5-hydroxymethylfurfural in 5% glucose injection were determined by high performance liquid chromatog.Results: Under the above-mentioned conditions, the properties, pH value, osmotic pressure, insoluble particles, related substances and the other contents showed no significant change.Conclusion: The caffeine citrate injection being compatible with 5% glucose injection, 0.9% sodium chloride injection or 10% calcium gluconate injection is stable and safe within 24 h.

Objective: To establish an HPLC method for the determination of related substances in chlorphenamine maleate injection.Methods: The HPLC was carried out on a C₁₈ column (4.6 mm × 250 mm, 5 μm) with a mobile phase of acetonitrile-0.857% of ammonium dihydrogen phosphate solution (20:80) (adjusted to pH 3.0 with phosphoric acid) at the flow rate of 1.2 mL/min and the detected UV wavelength of 225 nm.Results: Good separation among the peaks of chlorphenamine and impurity A, B, C, D was obtained.The detection limits of chlorphenamine and 4 impurities were 0.017, 0.016, 0.077, 0.030 and 0.053 μg/mL, resp.Conclusion: This method is simple, accurate with good specificity and high sensitivity and can be used for the anal. of related substances in chlorphenamine maleate injection.

A RP-HPLC method for the quant. anal. of disodium edetate in phenylephrine hydrochloride injection was established.RP-HPLC was performed using a Kromasil C₈ column (4.6 mm×250 mm, 5 μm) with the mobile phase of methanol-10% tetra-Bu ammonium hydroxide-98% formic acid-water (125: 12: 0.5: 875) and UV detection wavelength of 254 nm at the flow rate of 1.5 mL·min^-1 and column temperature of 40 degrees.The standard curve was linear over the range of 5.06-50.55 μg/mL (r=0.999) and the average recovery was 101.0% for disodium edetate.This method is simple, accurate, sensitive and good reproducible, and can be applied in the determination of disodium edetate in phenylephrine hydrochloride injection.