
Assay of Ferrous sulphate IP Pharmaceutical Analysis I Practical
Pharmaceutical Analysis I Practical: Limit test for (1) Chloride (2) Sulphate (3) Iron (4) Arsenic Preparation and standardisation of (1) Sodium hydroxide (2) Sulphuric acid (3) Sodium thiosulfate (4) Potassium permanganate (5) Ceric ammonium sulphate Assay (1) Ammonium chloride (2) Ferrous sulphate(3) Copper sulphate (4) Calcium gluconate (5) Hydrogen peroxide (6) Sodium benzoate (7) Sodium Chloride Determination of Normality (1) Conductometric titration of strong acid against a strong base (2) Conductometric titration of strong acid and weak acid against a strong base (3) Potentiometric titration
Aim
To determine the percent purity of Ferrous sulfate in a given sample
Principle
This determination is cerimetric type of redox titration. Ceric ammonium nitrate is a strong oxidizing agent that oxidizes ferrous ions to ferric ions and undergoes reduction to convert from ceric ion to cerous ion. Ferroin sulfate is used as an indicator which is a red-coloured complex of ferrous ions with 1, 10- phenanthroline. At the equivalence point excess of ceric ions converts ferrous in ferroin to ferric which changes the colour of the solution from red to light green colour
Standard
Ferrous sulphate contains not less than 98% and not more than 105 % of FeSO4.7H2O
Procedure
Dissolve 2.5g of sodium bicarbonate in a mixture of 150 ml of water and 10 ml of sulphuric acid. When effervescence ceases, add about 0.5 g of substance under examination, accurately weighed, shake gently to dissolve, and titrate with 0.1 M Ceric ammonium nitrate using 0.1 ml of ferroin solution as an indicator until the red colour disappears
Reference
Indian Pharmacopoeia 2014; Vol. II; Pg. No. 1753-1754.
Synopsis and Viva questions
Ferrous Sulfate IP is a pharmaceutical compound widely used for its iron supplement properties. In pharmaceutical analysis, it’s a crucial component in various formulations due to its stability and effectiveness.
The assay determines the purity and concentration of Ferrous Sulfate IP in a pharmaceutical sample. It ensures compliance with regulatory standards and verifies the efficacy of the product.
The assay can be performed through various methods like titrimetric, spectrophotometric, or gravimetric methods. Titrimetrically, it’s often assessed using standard solutions like potassium permanganate or cerium sulfate.
Challenges could include interference from impurities, oxidation of ferrous to ferric iron, or difficulties in achieving reproducibility due to varying sample characteristics.
Preparation involves ensuring proper calibration of instruments, accurate measurement of reagents, and careful sample handling to avoid contamination.
Avoid exposure to air to prevent oxidation, maintain consistent temperature and pH conditions, and adhere strictly to the specified procedures outlined in the pharmacopeia.
The assay result signifies the percentage of the active ingredient (Ferrous Sulfate IP) present in the sample, validating its potency and quality.
Variations can affect dosage accuracy and therapeutic efficacy, potentially leading to inadequate treatment outcomes or unexpected side effects.
Adherence to the assay protocol ensures the reliability and consistency of the pharmaceutical product, safeguarding its quality and effectiveness for patients.
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