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AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION

Category Antibacterial.

          Amoxicillin and Clavulanate Potassium for Oral Suspension contains the equivalent of not less than 90.0 per cent and not more than 120.0 per cent of the labelled amount of C16H19N3O5S and the equivalent of not less than 90.0 per cent and not more than 125.0 per cent of the labelled amount of C8H9NO5. It contains one or more suitable buffers, colours, flavours, preservatives, stabilizers, sweeteners, and suspending agents.

Strengths available 125 mg and 31.25 mg; 200 mg and 28.5 mg; 250 mg and 62.5 mg; and 400 mg and 57 mg of amoxicillin (anhydrous) and clavulanic acid, respectively, per 5 ml.

Dose Adults: 250 mg of amoxicillin and 62.5 mg of clavulanic acid every 8 hours for 7 to 10 days.
          Infants and children up to 40 kg of body weight: 6.7 mg of amoxicillin and 1.7 mg of clavulanic acid per kg of body weight every 8 hours for 7 to 10 days.

Contra-indication; Warning; Precaution; Additional information See under Penicillin V Potassium, p. 140.

Packaging and storage Amoxicillin and Clavulanate Potassium for Oral Suspension shall be kept in tightly closed containers and stored at a temperature not exceeding 25º. After constitution, it should be used within the period stated on the label.

Labelling The label on the container states (1) the quantity equivalent to the amount of amoxicillin; (2) the quantity equivalent to the amount of clavulanic acid.

Identification The retention times of the major peaks in the chromatogram of the Assay preparation correspond to those in the chromatogram of the Standard preparation, as obtained in the Assay.

pH 4.2 to 6.6, in the suspension constituted as directed in the labelling, the test being performed immediately after reconstitution (Appendix 4.11).

Water Not more than 7.5 per cent w/w, where the label indicates that after constitution as directed, the suspension contains an amount of amoxicillin that is less than 40 mg per ml; not more than 8.5 per cent where the label indicates that after constitution as directed the suspension contains an amount of amoxicillin that is equal to or more than 40 mg per ml and is less than or equal to 50 mg per ml; not more than 11.0 per cent w/w where the label indicates that after constitution as directed the suspension contains an amount of amoxicillin that is more than 50 mg per ml and is less than or equal to 80 mg per ml; and not more than 12.0 per cent w/w where the label indicates that after constitution as directed the suspension contains an amount of amoxicillin that is more than 80 mg per ml (Karl Fischer Method, Appendix 4.12).

Assay Carry out the determination as described in the “High-pressure Liquid Chromatography” (Appendix 3.5).

          pH 4.4 Sodium phosphate buffer Dissolve 7.8 g of sodium dihydrogenphosphate in 900 ml of water, adjust with phosphoric acid or 10 M sodium hydroxide to a pH of 4.4±0.1, dilute with water to make 1000 ml, and mix.
          Mobile phase Prepare a suitable mixture of 95 volumes of pH 4.4 sodium phosphate buffer and 5 volumes of methanol. Make adjustments if necessary.
          Standard preparation Dissolve accurately weighed quantities of Amoxicillin RS and Clavulanate Lithium RS in water to obtain a solution having known concentrations of about 500 μg per ml and 200 μg per ml, respectively.
          Assay preparation Dilute an accurately measured volume of Amoxicillin and Clavulanate Potassium for Oral Suspension, constituted as directed in the labelling,quantitatively with water to obtain a solution containing about 500 μg of amoxicillin per ml. Stir by mechanical means for 10 minutes, and filter. Use the filtrate as Assay preparation within 1 hour of the dilution of the suspension.
          Chromatographic system The chromatographic procedure may be carried out using (a) a stainless steel column (30 cm × 4 mm) packed with octadecylsilane chemically bonded to porous silica or ceramic microparticles (3 to 10 μm), (b) Mobile phase at a flow rate of about 2 ml per minute, and (c) an ultraviolet photometer set at 220 nm.
          To determine the suitability of the chromatographic system, chromatograph Standard preparation, and record the peak responses as directed under Procedure: the relative standard deviation for replicate injections is not more than 2.0 per cent, the resolution factor between the amoxicillin and clavulanic acid peaks is not less than 3.5, and the symmetry factor for the amoxicillin peak is not more than 1.5.
          Procedure Separately inject equal volumes (about 20 μl) of Standard preparation and Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. The relative retention times are about 0.5 for clavulanic acid and 1.0 for amoxicillin.
          Calculation Calculate the contents of amoxicillin (C16H19N3O5S) and of clavulanic acid (C8H9NO5) in each ml of the constituted Oral Suspension using the declared content of C16H19N3O5S in Amoxicillin RS and the declared content of C8H9NO5 in Clavulanate Lithium RS.

Other requirements Complies with the requirements described under “Oral Liquids” (Appendix 1.16).

 

MONOGRAPHS • AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION
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หมายเหตุ / Note : TP II 2011 PAGE 26 - 27