Validation of the analysis method of Diltiazem tablets 60 mg by UV-VIS spectrophotometry. Study of dissolution profiles
DOI:
https://doi.org/10.29076/issn.2528-7737vol13iss34.2020pp34-46pKeywords:
Dissolution profiles, Quality parameters, ValidationAbstract
Diltiazem, a calcium channel bloking benzothiazepine, is used to treatment of hypertension and partial obstruction of the coronary arteries, known as angina pectoris. In the present work, a comparative study of the quality parameters and dissolution profiles of the 60 mg tablets marketed in Ecuador against Incoril from Bagó laboratories was carried out.. The quantification method Diltiazem was validated by UV-VIS spectrophotometry. The validation made it to verify that the method was specific, sensitive and linear in a concentration of 60 mg with a correlation coefficient of r2 = 0.990. It was also precise, accurate and reproducible and in accordance with the analysis of the product. For the three batches studied there were no significant differences in the physicochemical parameters evaluated. The dissolution profiles showed marked differences in the release of the active ingredient in the maximum time of the sampling, which was 180 min. Of the three generic batches, only one complied with the factors f1 and f2 of difference and similarity and presented a better behavior in the dissolution rate and the efficiency percentage.
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