Calcium folinate assay

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Calcium folinate assay

Methods Calcium folinate analysis

The preparation contains not less than 90.0% and not more than 110.0% of calcium folinate from the declared amount of folinic acid C20H21CaN7O7.

According to structure of the drug, it should give a characteristic reaction for the calcium ion as the drug include calcium ion. Good example for this is burning of Ca ions. Flame of Ca which is in compound gives orange color

HPLC. The retention time of the active substance on the chromatogram of the test solution should correspond to the retention time of calcium folinate on the chromatogram of a calcium folinate standard sample solution

Substance chromaticity:

The preparation must withstand comparison with the Y2 standard (General Pharmacopoeia Monograph “Degree of color of liquids”, method 2).
All these acts are done by using the comparison method
рН: (Potentiometric pH measuring principle)
От 6,5 до 8,5

- the area of the peak of impurity D should not exceed the area of the main peak on the chromatogram of the solution of the standard sample of impurity D (not more than 1%);
- the peak area of any impurity, except for folinate and impurity D peaks, should not exceed the folinate peak area on the chromatogram of reference solution A (no more than 1%);
- the total area of peaks of all impurities, except for impurity D, should not exceed 2.5 times the area of the folinate peak on the chromatogram of reference solution A (not more than 2.5%);
Do not take into account peaks of the solvent and peaks whose area is less than the area of the folinate peak in the chromatogram of reference solution B (less than 0.1%).

The determination is carried out by HPLC under the conditions for the determination of related impurities.
Test solution: If necessary, the drug is diluted with water to a folinic acid concentration of 0.1 mg / ml.
Calcium folinate standard sample solution (A). About 10.8 mg (accurately weighed) of a standard sample of calcium folinate is placed in a volumetric flask with a capacity of 100 ml, dissolved in water and the volume of the solution is brought to the mark with the same solvent.

Calcium folinate standard sample solution (B). 1.0 ml of a solution of a standard sample of calcium folinate (A) is placed in a volumetric flask with a capacity of 10 ml and the volume of the solution is brought to the mark with water.
Calcium folinate impurity standard sample solution D. Use the solution prepared in the Related Impurities test.
Solution for testing the separation capacity of the chromatographic system.

5.0 ml of a solution of a standard sample of impurity D of calcium folinate is placed in a volumetric flask with a capacity of 10 ml and the volume of the solution is brought to the mark with a solution of a standard sample of calcium folinate (B).
The suitability of the chromatographic system (using a solution to test the separation ability of the chromatographic system) is determined in accordance with the General Pharmacopoeia Monograph "Chromatography" with the following specification. On the chromatogram of the separation capacity of the chromatographic system, the resolution (R) between the peaks of impurity D and folinate should be at least 2.2.

511,5	-	molecular weight of calcium folinate.
473,5	-	molecular weight of folinic acid.

For doing assay of Calcium folinate we use simple methods such as comparison and burning also modern method HPLC

1. Pharmacopoeia Monograph for calcium folinate
2. https://go.drugbank.com/spectra/ms_ms/255334
3. https://www.pharmacopoeia.com/Catalogue/Preview?uri=%2Fcontent%2Ffile%2Fproducts%2Fhealthandsafety%2FCat-923_GB.pdf

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