DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR PHARMACEUTICAL DOSAGE FORM
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Abstract
The forced degradation study and peak purity data confirmed that there was no
newlinemerging between peaks of active ingredients and any other degradation products as
newlinewell as other additives. Peak of degraded products were not interfering with the main
newlinedrug peaks. Thus, these degradation products have not been identified. Hence the
newlinespecificity of the proposed method was established.
newlineThe developed RP-UPLC method is simple, sensitive, rapid, linear, precise, rugged,
newlineaccurate, specific and robust. Hence it can be used for the routine analysis in their
newlinebulk and combine dosage form in quality control laboratory and stability studies.
newline