METHOD DEVELOPMENT AND VALIDATION OF DILTIAZEM IN PHARMACEUTICAL FORMS BY SPECTROPHOTOMETRIC QUANTITATIVE DETERMINATION
DOI:
https://doi.org/10.11603/2312-0967.2017.4.8340Keywords:
diltiazem, bromocresol green, acetone, spectrophotometric determination.Abstract
The aim of the work. Development of quality control methods, in particular, spectrophotometric determination of the quantitative content of diltiazem in the dosage forms «Diacordin 60» and «Diacordin 90 retard» on the basis of the reaction with bromocresol green, as well as validation of the developed methods.
Materials and Methods. The research objects are tablets «Diacordin 60» (Zentiva in SANOFI, Czech Republic, series 3010117) and tablets «Diacordin 90 Retard» (Zentiva in SANOFI, Czech Republic, series 3510317).
Reagents and solvents: A standard sample of diltiazem, bromocresol green, acetone.
Analytical equipments: Spectrophotometer Specord 200, electronic scales AVT-120-5DM, ultrasonic bath ELMASONICE60 H.
Results and Discussion. The technique of spectrophotometric determination of the quantitative content of diltiazem in the dosage forms «Diacordin 60» and «Diacordin retard 90» based on the reaction with bromocresol green was developed. The stoichiometric ratios of the reactive components «diltiazem-BKG», obtained by the methods of continuous changes and the saturation method, completely agree with each other and amount 1:1. Based on such validation characteristics as linearity, precision, accuracy and robustness, the technique is correct and can be used in technical departments control of chemical and pharmaceutical enterprises.
Conclusions. As a result of the work, it was found that diltiazem reacts with BKG in an acetone medium at room temperature to form a colored product with a maximum absorption at 408 nm. The investigated reaction is highly sensitive: the molar absorption coefficient is 11547, and the opening minimum is 1.79 μg / ml.
It is proved that the methodology developed by such validation characteristics as linearity, precision, correctness and robustness is correct and can be used in the departments of technical control of chemical and pharmaceutical enterprises.
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