Chlorpromazine hydrochlorid

Thorazine Spansules Chlorpromazine hydrochloride SmithKline Beecham... 

Admixture Incompatibilities Physical incompatibilities resulted when linezolid IV injection was combined with the following drugs during simulated Y-site administration amphotericin B, chlorpromazine hydrochloride, diazepam, pentamidine isothionate, erythromycin lactobionate, phenytoin sodium, and trimethoprim-sulfamethoxazole. Additionally, chemical incompatibility resulted when linezolid IV injection was combined with ceftriaxone sodium. 

Chlorpromazine 2601-A, HL-5746, R-P-4560, SKF-2601-A [3] chlorpromazine hydrochloride, aminazine, chlorpromazini hydrochloridum, cloridrato de clorpromazinea [5]... 

The x-ray powder diffraction pattern of chlorpromazine hydrochloride was obtained in our laboratory [13], using a Philips fully automated X-ray... 

The powder pattern of chlorpromazine hydrochloride is presented in Figure 1, and the scattering angles, interplanar distances, and peak relative intensities are collected in Table 1. 

The melting range reported for chlorpromazine free base is 56-58°C [5], while the melting range of chlorpromazine hydrochloride has been reported to be 195-198 [8]. 

The DSC thermogram of chlorpromazine hydrochloride shown in Figure 2 was obtained using Du Pont model 9900 differential scanning calorimetry system, using a sample size of 2.83 mg and a heating rate of 10°C/minute [13]. 

Figure 1. X-ray powder diffraction pattern of chlorpromazine hydrochloride.

Crystallographic Data from the X-Ray Powder Diffraction Pattern of Chlorpromazine Hydrochloride... 

Figure 2. Differential scaiming calorimetry thermogram of chlorpromazine hydrochloride.

Chlorpromazine hydrochloride is soluble to the degree of 1 part in 0.4 parts of water, 1 part in 1.3 parts of alcohol, 1 part in 1 part of chloroform, and practically insoluble in ether [4]. It has also been reported to be soluble in methanol, ethanol, and chloroform, and to be practically insoluble in ether and benzene [3],... 

A 5% aqueous solution of chlorpromazine hydrochloride exhibits a pH in the range of 4.0-5.5, and is therefore slightly acidic to litmus [3]. 

UV spectroscopic studies of chlorpromazine hydrochloride were conducted in ethanol and water solutions, and the resulting spectra are shown in Figure 3. The data were obtained between 200 and 345 nm using a Shimadzu 1601 PC UVA IS spectrophotometer (Figure 3). 

The UV spectrum of chlorpromazine hydrochloride has also been obtained in aqueous acid, showed maximum a absorbance at 255 nm (for which A,o/, = 1025) [8]. 

Clarke has reported that the principal infrared absorption peaks of chlorpromazine hydrochloride are found at energies of 747,1240, 1561, 1125,1095,1220 cm [8]. 

The IR spectrum of chlorpromazine hydrochloride as a 1% dispersion in a KBr pellet was obtained in this laboratory using a Perkin-Elmer 580 B spectrometer. The spectrum is shown in Figure 4, and structural assignments have been correlated with group frequencies in Table 2 [13]. 

Figure 4. Infrared absorption spectrum of chlorpromazine hydrochloride. 

The H nuclear magnetic resonance spectrum of chlorpromazine hydrochloride in CDCI3 is shown in Figure 5 [13]. The data were recorded on a Varian XL 200 MHz spectrometer using tetramethylsilane as the internal reference. Assignments for the observed resonance bands are presented in Table 3. 

The mass spectrum of chlorpromazine hydrochloride was obtained using a Shimadzu PQ-5000 mass spectrometer [13], In this study, the parent ion was collided with helium as the carrier gas, and an ionization beam energy of 70 eV was used. The mass spectrum thusly obtained is presented in Figure 7. The molecular ion peak was observed at m/z = 318.2, and the base peak was at m/z = 58.2. Assignments for the fragmentation pattern, the peak relative intensities, and the proposed structures are found in Table 5. 

Treatment of chlorpromazine hydrochloride solution in H2O or in 0.5 N H2SO4 with concentrated H2SO4 (cooling in ice-cold water during the reaction), will give a pink color if the mixture is subsequently heated on a boiling water-bath and then re-cooled... 

The British Pharmacopoeia has adopted the assay of chlorpromazine in acetone, using a non-aqueous titration with perchloric acid and methyl orange as the indicator [4], According to the described procedure, each mL of 0.1 M perchloric acid is equivalent to 0.03189 g of drug substance. For chlorpromazine hydrochloride, the BP has described its titration with NaOH in a 1 10 solution of 0.01 M HCl / ethanol. Determining the end point potentiometrically, each mL of 0.1 M sodium hydroxide is equivalent to 0.03558 g of substance. 

The United States Pharmacopoeia has used a method similar to that of the BP for chlorpromazine, but which uses crystal violet as the indicator [7]. For chlorpromazine hydrochloride, the USP has described its titration with 0.1 M perchloric acid in glacial acetic acid (containing Hg(ll) acetate), and a potentiometric determination of the end point. 

Chlorpromazine hydrochloride was assayed in neutral solvents such as acetone or acetonitrile with a glacial acetic acid solution of perchloric acid. The combination of methyl violet and bromcresol green served as a mixed indicator [57]. 

A precipitation titration method has been reported where chlorpromazine hydrochloride is precipitated from solutions using excess standard Cdlj in the presence of K1 or HI, and the excess Cdl2 in the filtrate is then determined complexometrically using xylenol orange as the indicator [58]. 

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