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Adv Pharm Bull. 2018;8(4): 657-666.
doi: 10.15171/apb.2018.074
PMID: 30607338
PMCID: PMC6311631
Scopus ID: 85057756457
  Abstract View: 1470
  PDF Download: 995

Research Article

Analytical Investigation of the Possible Chemical Interaction of Methyldopa with Some Reducing Carbohydrates Used as Pharmaceutical Excipients

Mohammad Reaz Siahi 1,2 ORCID logo, Soma Rahimi 3 ORCID logo, Farnaz Monajjemzadeh 4,2* ORCID logo

1 Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
2 Department of Pharmaceutical and Food Control, Tabriz University of Medical Sciences, Faculty of Pharmacy, Tabriz, Iran.
3 Student Research Committee, Tabriz University of Medical Sciences, Faculty of Pharmacy, Tabriz, Iran.
4 Food and Drug Safety Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
*Corresponding Author: Email: farnaz_m76@yahoo.com

Abstract

Purpose: Assessment of drug substance and excipients compatibility is an important issue during pre-formulation studies as well as the quality control of pharmaceutical dosage forms. In this study, potential incompatibility between methyldopa and reducing excipients was evaluated using physicochemical methods. Methods: Dextrose and lactose (anhydrous & monohydrate) were selected as reducing carbohydrates. The initial incompatibility was studied with DSC and FTIR on binary mixtures with 1:1 mass ratio. Results were confirmed using HPLC studies coupled with mass spectrometry. Results: The DSC curves indicated the elimination of the melting endotherm of methyldopa in the binary mixtures. A new peak at 1719 cm-1 was observed in the FTIR spectra that can be attributed to the loss of type one amine functionality. The m/z of the proposed compound was observed in the mass spectra. Conclusion: The potential incompatibility of Methyldopa with reducing carbohydrates was established using physicochemical methods.
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Submitted: 30 Jan 2018
Revision: 29 Aug 2018
Accepted: 07 Oct 2018
ePublished: 29 Nov 2018
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