Dispersible Aciclovir Tablets
Action and use
Purine nucleoside analogue; antiviral (herpesviruses).
Definition
Dispersible Aciclovir Tablets contain Aciclovir in a suitable dispersible basis.
Content of aciclovir, C8H11N5O3
95.0 to 105.0% of the stated amount.
Identification
TESTS
Related substances
Carry out the method for liquid chromatography, Appendix III D, using the following solutions. Prepare a solution using the following solutions in a solvent mixture of 1 volume of dimethyl sulfoxide and 4 volumes of water unless otherwise indicated.
The test is not valid unless:
in the chromatogram obtained with solution (4), the resolution between the peaks due to impurity C and aciclovir is at least 1.5;
in the chromatogram obtained with solution (5), the resolution between the peaks due to impurity F and impurity A is a least 1.5 and the resolution between the peaks due to impurity K and impurity G is at least 1.5.
In the chromatogram obtained with solution (1):
identify any peak corresponding to impurity I using the chromatogram obtained with solution (4) and the chromatogram supplied with aciclovir for peak identification 1 EPCRS and multiply the area by a correction factor of 1.5;
the area of any peak corresponding to impurity B is not greater than 5 times the area of the principal peak in the chromatogram obtained with solution (2) (1.0%);
the area of any peak corresponding to impurity O is not greater than 1.5 times the area of the principal peak in the chromatogram obtained with solution (2) (0.3%);
the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (0.2%);
the sum of the areas of any secondary peaks is not greater than 10 times the area of the principal peak in the chromatogram obtained with solution (2) (2.0%).
Disregard any peak with an area less than 0.25 times the area of the principal peak in the chromatogram obtained with solution (2) (0.05%).
Assay
Weigh and finely powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in a mixture of 1 volume of dimethyl sulfoxide and 4 volumes of water, unless otherwise indicated.
The chromatographic conditions described under Related substances may be used.
The test is not valid unless, in the chromatogram obtained with solution (3), the resolution between the peaks due to impurity C and aciclovir is at least 1.5.
Calculate the content of C8H11N5O3 in the tablets using the declared content of C8H11N5O3 in aciclovir BPCRS.
Impurities
The impurities limited by the requirements of this monograph include those listed under Aciclovir.