Action and use
Cyclo-oxygenase inhibitor; analgesic; anti-inflammatory.
DEFINITION
Meloxicam Oral Suspension is a suspension of Meloxicam in a suitable vehicle.
The oral suspension complies with the requirements stated under Oral Liquids and with the following requirements.
Content of meloxicam, C14H13N3O4S2
95.0 to 105.0% of the stated amount.
IDENTIFICATION
A. Carry out the method for thin-layer chromatography, Appendix III A, using the following solutions.
(1) Dilute a quantity of the oral suspension containing 3 mg of Meloxicam to 10 mL with acetone, stir for 10 minutes, filter and use the filtrate.
(2) Dissolve 3 mg of meloxicam BPCRS in about 5 mL of acetone, add 0.5 mL of water and dilute to 10 mL with acetone.
CHROMATOGRAPHIC CONDITIONS
(a) Use as the coating high-performance silica gel F254 (Merck silica gel 60 F254 HPTLC plates are suitable).
(b) Use the mobile phase as described below.
(c) Apply 5 μL of each solution.
(d) Develop the plate to 8 cm.
(e) After removal of the plate, allow it to dry in air and examine under ultraviolet light (254 and 365 nm).
MOBILE PHASE
1 volume of 13.5M ammonia, 20 volumes of methanol and 80 volumes of dichloromethane.
CONFIRMATION
By each method of visualisation the principal spot in the chromatogram obtained with solution (1) is similar in position, colour and size to that in the chromatogram obtained with solution (2).
B. Disperse a quantity of the oral suspension containing 1.5 mg of Meloxicam in 5 mL of 0.1M sodium hydroxide, dilute to 100 mL with methanol and filter. The light absorption of the filtrate, Appendix II B, in the range 340 to 450 nm exhibits a maximum at 362 nm.
ASSAY
Carry out the method for liquid chromatography, Appendix III D, using the following solutions.
(1) Mix a quantity of the oral suspension containing 15 mg of Meloxicam with sufficient of the mobile phase to produce 200 mL, mix with the aid of ultrasound for 30 minutes and filter.
(2) 0.0075% w/v of meloxicam BPCRS in the mobile phase.
CHROMATOGRAPHIC CONDITIONS
(a) Use a stainless steel column (10 cm × 4 mm) packed with octadecylsilyl silica gel for chromatography (10 μm) (Nucleosil C18 is suitable) and a pre-column 1-cm long packed with the same material.
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 0.8 mL per minute.
(d) Use a column temperature of 40°.
(e) Use a detection wavelength of 254 nm.
(f) Inject 20 μL of each solution and continue the chromatography for twice the retention time of the principal peak.
MOBILE PHASE
35 volumes of a mixture containing 10 parts of propan-2-ol and 65 parts of methanol and 65 volumes of a 0.2% w/v solution of diammonium hydrogen orthophosphate previously adjusted to pH 7.0 with orthophosphoric acid.
DETERMINATION OF CONTENT
Determine the weight per mL of the oral suspension, Appendix V G, and calculate the content of C14H13N3O4S2, weight in volume, from the declared content of C14H13N3O4S2 in meloxicam BPCRS.
