Analysis method of Ferrous Ascorbate with Folic Acid suspension
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Ferrous Ascorbate with Folic Acid Suspension.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Ferrous Ascorbate with Folic Acid Suspension in Quality control
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 Procedure
5.1 Description: Pour 50 ml finish sample in beaker and observed visually.
5.2 pH: Taken 50 ml sample in beaker rinse the pH electrode first with purified water followed by sample dip the electrode in sample and observed the pH.
5.3 Volume variation: Measured the volume by measuring cylinder and determine the volume variation.
5.4 Identification:
5.4.1 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained with the reference solution. and by chemical method.
5.5 ASSAY:
Each 5ml contains:
Ferrous Ascorbate
eq.to Elemental Iron. 30mg.
Folic Acid I.P 550mcg.
Method of Ferrous Ascorbate with Folic Acid Suspension.
Estimation of Ferrous Ascorbate Eq.to Iron.
Method of iron:
Weigh accurately equivalent to 50 mg of iron and 5 ml water. add 3ml sulphuric acid. heat and cool. Add potassium permanganate solution till. Change the colour pale yellow or disappear colour add 2 gm potassium iodide. After that 25 ml Hcl stay on 5 to 10 minute. Add starch solution as indicator. Titrate with 0.1 M sodium Thiosulphate.
Factor-5.85 mg
V= Volume (in ml) of Sodium Thiosulphate. Solution consumed in titration.
N = Actual Normality of Sodium Thiosulphate Solution.
AW= Average weight
Wt. = Weight of Sample.
Calculation:
Estimation of Folic Acid.
Buffer: 680 mg potassium dihydrogen orthophosphate dissolve in 100 ml water. Adjust to ph-6.0 with
1N sodium hydroxide.
Mobile phase: Buffer : methanol
90 : 10
Standard preparation: weigh accurately 50 mg of folic acid in 100 ml volumetric with 0.1N Sodium hydroxide. Further dilution 1.0ml to 50 ml with mobile phase.
Sample preparation: weight accurately equivalent to 1.0mg of sample weight add 10 ml of 0.1 N Sodium hydroxide shake for 5 minute. And diluted to 100 ml volumetric flask
With mobile phase.
Chromatographic condition:
Wavelength -280 nm
Column -C18 (250 x4.6) mm
Flow -1.2ml per minute.
Injection volume -10 micro liter.
Retention time about 15 mint.
Temperature – Ambient
Calculation:
6.0 Abbreviation
Sr. No. Abbreviation used Full form of abbreviation used
1.0 STP Standard Testing Procedure
2.0 QA Quality assurance
3.0 STD Standard
4.0 SPL Sample
5.0 NM Nano Meter
7.0 (ANNEXURE)
NA
8.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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