Analysis of Carbamazepine, Oxcarbazepine, Their Impurities, and Non-Labeled Interfering Substances by Stability-indicating UPLC/MS/MS Method: Studying the Method’s Greenness Profile
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Carbamazepine (CBZ) and oxcarbazepine (OX) are highly effective anti-psychotic drugs. In USP, it is stated that CBZ has several impurities including, iminodibenzyl (IDB), iminostilbene (IMS), and 9-methylacridine (MA). While, for OX, it is reported to have impurities like, CBZ, IMS and 9-methylacridine (MA). Presence of such impurities in various forms may reduce the efficacy and increase the side effects. It is declared that CBZ (Tegretol®) and OX (Trileptal®) oral suspensions contain methylparaben, propylparaben, and sorbic acid as preservatives. For the first time, CBZ and OX were determined with their impurities and formulation excipients with a highly selective and sensitive ecofriendly LC/MS/MS method using methanol: water containing 0.1% formic acid (95:5, v/v) as a mobile phase. Mass spectrometric quantitation was carried out in positive and negative ion modes. Application of the proposed method to quantify CBZ and OX in their tablets and oral suspensions was successfully done. The results obtained by the suggested method and the reported methods for both drugs agreed well with each other. The developed method has the advantage of being ecofriendly using the simple green mobile phase. Unlike other published methods, it is successfully applied to quantify the impurities and excipients along with parent drugs within limits recommended by USP guidelines.
KeywordsLC/MS/MS Carbamazepine Oxcarbazepine Impurities Formulation excipients Greenness profile
Both Dr. MMA and Dr. NSA did the practical work and wrote the manuscript.
Compliance with ethical standards
Conflict of interest
Authors A declares that she has no conflict of interest. Authors B declares that she has no conflict of interest.
Research involving human participants and/or animals
No human volunteers or animals were used in this work.
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