Cefaclor Capsules

General Notices

Action and use

Cephalosporin antibacterial.

Definition

Cefaclor Capsules contain Cefaclor.

The capsules comply with the requirements stated under Capsules and with the following requirements.

Content of anhydrous cefaclor, C15H14ClN3O4S

95.0 to 105.0% of the stated amount.

Identification

A. Shake a quantity of the contents of the capsules containing the equivalent of 0.3 g of anhydrous cefaclor with 100 mL of water, filter and dilute 1 mL of the filtrate to 100 mL with water. The light absorption, Appendix II B, in the range 190 nm to 310 nm, of the final solution exhibits a maximum only at 264 nm.
B. In the Assay, 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).

Tests

Dissolution

Comply with the requirements for Monographs of the British Pharmacopoeia in the dissolution test for tablets and capsules, Appendix XII B1.

test conditions
(a) Use Apparatus 2, rotating the paddle at 50 revolutions per minute.
(b) Use 900 mL of water, at a temperature of 37°, as the medium.
procedure
(1) After 45 minutes withdraw a 10 mL sample of the medium, filter and dilute the filtered solution, if necessary, with sufficient water to produce a solution expected to contain the equivalent of about 0.025% w/v of anhydrous cefaclor. Measure the absorbance of the filtered sample at the maximum at 264 nm, Appendix II B, using water in the reference cell.
(2) Measure the absorbance of a 0.025% w/v solution of cefaclor BPCRS in water using water in the reference cell.
determination of content

Calculate the total content of anhydrous cefaclor, C15H14ClN3O4S, in the medium from the absorbances obtained and using the declared content of C15H14ClN3O4S in cefaclor BPCRS.

Related substances

Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a 0.27% w/v solution of sodium dihydrogen orthophosphate which has been adjusted to pH 2.5, if necessary, with orthophosphoric acid (solution A). The solutions should be freshly prepared.

(1) Shake a quantity of the contents of the capsules containing the equivalent of 0.5 g of anhydrous cefaclor with 200 mL of solution A, add sufficient of solution A to produce 250 mL and filter.
(2) 0.002% w/v of cefaclor BPCRS.
(3) 0.0025% w/v of cefaclor BPCRS and 0.005% w/v of delta-3-cefaclor BPCRS.
chromatographic conditions
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Spherisorb ODS-2 is suitable).
(b) Use gradient elution and the mobile phase described below.
(c) Use a flow rate of 1 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 220 nm.
(f) Inject 20 µL of each solution.
mobile phase
Mobile phase AA 0.78% w/v solution of sodium dihydrogen orthophosphate adjusted to pH 4.0 with orthophosphoric acid.
Mobile phase BMix 450 volumes of acetonitrile with 550 volumes of mobile phase A.

Equilibrate the column with a mixture of 5 volumes of mobile phase B and 95 volumes of mobile phase A for at least 15 minutes. Inject the solutions and carry out the following gradient elution.

system suitability

The test is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to cefaclor and delta-3-cefaclor is at least 2.0. If necessary, adjust the proportion of acetonitrile in the mobile phase.

limits

In the chromatogram obtained with solution (1):

the area of any secondary peak is not greater than half the area of the principal peak in the chromatogram obtained with solution (2) (0.5%);

the sum of the areas of any such peaks is not greater than twice the area of the principal peak in the chromatogram obtained with solution (2) (2%).

Disregard any peak with an area less than 0.1 times the area of the principal peak in the chromatogram obtained with solution (2) (0.1%).

Assay

Carry out the method for liquid chromatography, Appendix III D, using the following solutions.

(1) Shake a quantity of the powdered, mixed contents of 20 capsules containing the equivalent of 75 mg of anhydrous cefaclor with the mobile phase, add sufficient mobile phase to produce 250 mL and filter.
(2) 0.03% w/v of cefaclor BPCRS in the mobile phase.
(3) 0.03% w/v of each of cefaclor BPCRS and delta-3-cefaclor BPCRS in the mobile phase.
chromatographic conditions
(a) Use a stainless steel column (25 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Beckman Ultrasphere ODS and Supelcosil LC-18-DB are suitable).
(b) Use isocratic elution and the mobile phase described below.
(c) Use a flow rate of 1.5 mL per minute.
(d) Use an ambient column temperature.
(e) Use a detection wavelength of 265 nm.
(f) Inject 20 µL of each solution.
mobile phase

Dissolve 1 g of sodium pentanesulfonate in a mixture of 780 mL of water and 10 mL of triethylamine, adjust the pH to 2.5 using orthophosphoric acid, add 220 mL of methanol and mix.

system suitability

The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks due to cefaclor and delta-3-cefaclor is at least 2.5 and the symmetry factor of the peak due to cefaclor is at most 1.5.

determination of content

Calculate the content of C15H14ClN3O4S in the capsules from the chromatograms obtained and using the declared content of C15H14ClN3O4S in cefaclor BPCRS.

Storage

Cefaclor Capsules should be stored at a temperature not exceeding 30°.

Labelling

The quantity of active ingredient is stated in terms of the equivalent amount of anhydrous cefaclor.