We have developed HPLC method for estimation of Sodium metabisulfite in oral suspension. Method validation completed with Spiked samples.
Question is when we analyse actual test product, assay values obtained are less than 10% of label claim. When confirmed that input in product is correct.
Need suggestions.
Thanks
Dear 29m ago
Mahesh Enagi,
Mostly the suspension types of formulation contain Hypromellose which is solution in acidic level solvents like 0.1N HCL or 30% Methanolic HCL or other suitable combination.
Many times it is observed that the spiking study is perfect i.e 100% observing in method however sample gives issue because drug gets trapped with excipients which needs more suitable solvents. In such case take the formulation with overages like 10 to 50% and check your diluent system on the same.
This way you can solve the issue.
Another losses can be happened in suspension that the weighing of sampling and mixing of sample before weighing. In such case you have to vortex sample or homogenized the same and weighed carefully. Ensure sample should not settled down immediately or cake formation,
Feel free to ask if query any
Typically, concentrations of Sodium Metabisulphite are determined by titration with Potassium Thiosulfate using a starch endpoint. In this case it sounds more like the metabisulphite has been transformed by the sample matrix into another ionic form, thus we need more information (like sample matrix, chromatographic conditions, column, mobile phases, detector...)!
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