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Calcium Folinate Tablets | |
| Action and use | Vitamin B component. |
Definition | Calcium Folinate Tablets contain Calcium Folinate. The tablets comply with the requirements stated under Tablets and with the following requirements. |
Content of folinic acid, C20H23N7O7 | 90.0 to 110.0% of the stated amount. |
Identification | A. Shake a quantity of the powdered tablets containing the equivalent of 15 mg of folinic acid with 150 ml of 0.1m sodium hydroxide and dilute to 200 ml with the same solvent. Filter and dilute 10 ml of the clear filtrate to 50 ml with 0.1m sodium hydroxide. The light absorption of the resulting solution, Appendix II B, in the range 220 to 350 nm exhibits a maximum at about 282 nm. B. In the test for Related substances, the chromatogram obtained with solution (2) shows a peak with the same retention time as the principal peak in the chromatogram obtained with solution (4). |
Tests Related substances | Protect the solutions from light. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. (1) Add 20 ml of water to a quantity of the powdered tablets containing the equivalent of 25 mg of folinic acid, shake for 15 minutes and dilute to 25 ml with water. Filter through a glass fibre filter (Whatman GF/C is suitable). (2) Dilute 1 volume of solution (1) to 100 volumes with water. (3) 0.001% w/v of formylfolic acid EPCRS in the mobile phase. (4) 0.001% w/v of calcium folinate EPCRS in water. (5) 0.0001% w/v of calcium folinate EPCRS in water. (6) Mix 10 volumes of solution (3) with 5 volumes of solution (4). chromatographic conditions (a) Use a stainless steel column (25 cm × 4.6 mm) packed with end-capped octadecylsilyl silica gel for chromatography (5 µm) (Hypersil ODS is suitable). (b) Use isocratic elution and the mobile phase described below. (c) Use a flow rate of 1 ml per minute. (d) Use a column temperature of 40°. (e) Use a detection wavelength of 280 nm. (f) Inject 20 µl of each solution. mobile phase A mixture of 220 ml of methanol and 780 ml of a solution containing 2.0 ml of tetrabutylammonium hydroxide solution and 2.2 g of disodium hydrogen orthophosphate and previously adjusted to pH 7.5 with 10% v/v orthophosphoric acid. system suitability The test is not valid unless, in the chromatogram obtained with solution (6), the resolution factor between the peaks corresponding to calcium folinate and formylfolic acid is at least 2.2. If necessary, adjust the methanol content in the mobile phase. limits In the chromatogram obtained with solution (1): the area of any peak corresponding to formylfolic acid is not greater than the area of the principal peak in the chromatogram obtained with solution (3) (1%); the area of any other secondary peak is not greater than the area of the principal peak in the chromatogram obtained with solution (2) (1%); the sum of the areas of any secondary peaks is not greater than 2.5 times the area of the principal peak in the chromatogram obtained with solution (2) (2.5%). Disregard any peak with an area less than that of the principal peak in the chromatogram obtained with solution (5) (0.1%). |
Assay | Protect the solutions from light. Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions. (1) Add 200 ml of water to a quantity of the powdered tablets containing the equivalent of 25 mg of folinic acid, shake for 15 minutes and dilute to 250 ml with water. Filter through a glass fibre filter (Whatman GF/C is suitable). (2) 0.011% w/v of calcium folinate EPCRS in water. (3) 5 volumes of a 0.001% w/v solution of formylfolic acid EPCRS in the mobile phase and 10 volumes of a 0.001% w/v solution of calcium folinate EPCRS in water. chromatographic conditions The chromatographic conditions described under Related substances may be used. system suitability The Assay is not valid unless, in the chromatogram obtained with solution (3), the resolution factor between the peaks corresponding to calcium folinate and formylfolic acid is at least 2.2. If necessary, adjust the methanol content in the mobile phase. determination of content Calculate the content of folinic acid, C20H23N7O7 using the declared content of C20H21CaN7O7, in calcium folinate EPCRS. Each mg of C20H21CaN7O7 is equivalent to 0.926 mg of C20H23N7O7. |
| Storage | Calcium Folinate Tablets should be stored at a temperature not exceeding 30°. |
Labelling | The quantity of active ingredient is stated in terms of the equivalent amount of folinic acid. |
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