manufacturing procedure:
Slugging of Amlodipine + Valsartan+(binder & disintegrante) then crushing and adding hydrochlorothiazide with other excipient as extra dry granulation then blending.
We faced problem in uniformity of blend for the extra slug API (Hydrochlorothiazide), there is variation in the result of assay for this API, While the other 2 API are within the accepted limit of assay.
Note that hydrochlorothiazide is fine powder, we tried to uniform particle size by passing the dried granules through mesh size 0.5 mm but still the variation exist!!
any recommendation to resolve this problem,?
Try adding a glidant to help dispersion and avoid agglomeration and segregation. Make sure that the analytical technique is suitable and everithing is in solution before analysis.
Take one or two company marketed product and your product. Analysis and compare them. Correct your analysis method or formulation.
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