Cimetidine-Tablets-8346
Cimetidine Tablets
General Notices
Action and use
Histamine H2 receptor antagonist; treatment of peptic ulceration.
DEFINITION
Cimetidine Tablets contain Cimetidine.
The tablets comply with the requirements stated under Tablets and with the following requirements.
Content of cimetidine, C
10H
16
N
6
S
95.0 to 105.0% of the stated amount.
IDENTIFICATION
A. Shake a quantity of the powdered tablets containing 0.10 g of Cimetidine with 10 ml of methanol for 10 minutes, filter (Whatman GF/A is suitable) and evaporate to dryness on a rotary evaporator using gentle heat. Dissolve the residue in 5 ml of chloroform and evaporate to dryness with the aid of a current of air. Dry the residue at 60° at a pressure not exceeding 0.7 kPa. The infrared absorption spectrum of the residue, Appendix II A, is concordant with the reference spectrum of cimetidine (RS 061).
B. In the test for Related substances, the principal spot in the chromatogram obtained with solution (2) corresponds to that in the chromatogram obtained with solution (6).
TESTS
Related substances
Carry out the method for thin-layer chromatography, Appendix III A, using silica gel GF254 as the coating substance and using the following solutions. For solution (1) add 20 ml of methanol to a quantity of the powdered tablets containing 1 g of Cimetidine, mix with the aid of ultrasound for 2 minutes, shake for 3 minutes and filter using a suitable 0.2-μm filter. For solution (2) dilute 1 volume of solution (1) to 10 volumes with methanol. For solution (3) dilute 1 volume of solution (2) to 20 volumes with methanol. For solution (4) dilute 1 volume of solution (1) to 100 volumes with methanol and dilute 20 volumes of this solution to 100 volumes with methanol. For solution (5) dilute 5 volumes of solution (4) to 10 volumes with methanol. Solution (6) contains 0.50% w/v of cimetidine BPCRS in methanol. Carry out the following tests.
A. Apply separately to the plate 4 μl of each solution. Allow the plate to stand for 15 minutes in the tank saturated with vapour from the mobile phase which consists of a mixture of 15 volumes of 13.5M ammonia, 20 volumes of methanol and 65 volumes of ethyl acetate. After development and removal of the plate, dry it in a current of cold air, expose to iodine vapour until maximum contrast of the spots has been obtained and examine under ultraviolet light (254 nm).
B. Apply separately to the plate 4 μl of each solution. Develop using a mixture of 8 volumes
B. Apply separately to the plate 4 μl of each solution. Develop using a mixture of 8 volumes of 13.5M ammonia, 8 volumes of methanol and 84 volumes of ethyl acetate. After removal of the plate, dry it in a current of cold air, expose to iodine vapour until maximum contrast of the spots has been obtained and examine under ultraviolet light (254 nm).
The following limits apply to both methods. Any secondary spot in the chromatogram obtained with solution (1) is not more intense than the principal spot in the chromatogram obtained with solution (3) (0.5%) and not more than two such spots are more intense than the principal spot in the chromatogram obtained with solution (4) (0.2% of each). The tests are not valid unless the chromatograms obtained with solution (5) show clearly visible spots.
ASSAY
Weigh and finely powder 20 tablets. Shake a quantity of the powdered tablets containing 0.1 g of Cimetidine with 300 ml of 0.05M sulphuric acid for 20 minutes, add sufficient 0.05M sulphuric acid to produce 500 ml and filter (Whatman GF/C is suitable). Dilute 5 ml of the filtrate to 100 ml with 0.05M sulphuric acid (solution A). Prepare a 0.001% w/v solution of cimetidine BPCRS in 0.05M sulphuric acid (solution B). Measure the absorbance of solutions A and B at the maximum at 218 nm and at 260 nm, Appendix II B. Calculate the content of
C10H16N6S using the difference between the absorbances of solutions A and B at the two wavelengths and the declared content of C10H16N6S in cimetidine BPCRS.
Ciprofloxacin Intravenous Infusion
General Notices
Action and use
Fluoroquinolone antibacterial.
DEFINITION
Ciprofloxacin Intravenous Infusion is a sterile solution, in Glucose Intravenous Infusion or in Sodium Chloride Intravenous Infusion, of ciprofloxacin lactate prepared by the interaction of Ciprofloxacin and Lactic Acid.
The intravenous infusion complies with the requirements stated under Parenteral Preparations and with the following requirements.
Content of ciprofloxacin, C
17H
18
FN
3
O
3
95.0 to 105.0% of the stated amount.
IDENTIFICATION
A. Carry out the method for thin-layer chromatography, Appendix III A, using a silica gel F254 high-performance precoated plate (Merck silica gel 60 F254 HPTLC plates are suitable) and a mixture of 10 volumes of acetonitrile, 20 volumes of 13.5M ammonia, 40 volumes of dichloromethane and 40 volumes of methanol as the mobile phase. Apply separately to the plate, as bands, 10 μl of each of the following solutions. For solution (1) dilute a quantity of the intravenous infusion with sufficient water to produce a solution containing the equivalent of 0.05% w/v of ciprofloxacin. Solution (2) contains 0.058% w/v of ciprofloxacin hydrochloride EPCRS in water. For solution (3) mix 1 volume of solution (1) and 1 volume of solution (2). After removal of the plate, allow it to dry in air for 15 minutes and examine under ultraviolet light (254 nm and 365 nm). The principal band in the chromatogram obtained with solution (1) corresponds to that in the chromatogram obtained with solution (2) . The principal band in the chromatogram obtained with solution (3) appears as a single, compact band.
B. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. For solution (1) use the preparation being examined diluted, if necessary, with water to produce a solution containing the equivalent of 0.2% w/v of ciprofloxacin. Solution (2) contains 0.07% w/v of lithium lactate BPCRS in water.
The chromatographic procedure may be carried out using (a) a stainless steel column (30 cm × 7.8 mm) packed with a strong cation-exchange resin of sulphonated, cross-linked styrene-divinylbenzene copolymer in the hydrogen form (7 to 11 μm) (Aminex HPX-87 H is suitable), (b) as the mobile phase with a flow rate of about 0.6 ml per minute a degassed mixture of 15 volumes of acetonitrile and 85 volumes of 0.0025M sulphuric acid and (c) a detection wavelength of 208 nm. Maintain the temperature of the column at 40°. After each analysis the column should be rinsed with a mixture of 0.005M sulphuric acid and acetonitrile and then regenerated with 0.025M sulphuric acid.
The chromatogram obtained with solution (1) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (2).