A specific new analytical method for determining linagliptin in pure and combination drug products (Empagliflozin and Metformin)
Abstract
Abstract Linagliptin is an oral antidiabetic agent, used to treat type 2 diabetes. It is taken orally independently or in combination with Empagliflozin and Metformin HCl. Chromatographic Analysis methods were demonstrated for simultaneous analysis of two or three antidiabetic drugs (Linagliptin, Empagliflozin and/or Metformin). This article is interested in the validation of a simple, fast and specific method that relies on chemical derivatization and uses a VIS spectrophotometer to determine LINA in pure and combination drug products alongside Empagliflozin and Metformin. The developed method was reached by reacting LNG with Para-Dimethylaminobenzaldehyde (PDAB) 5% in an acidic medium (Hydrochloride 37%) in a water bath to produce a yellow Schiff base which can be measured at a wavelength of 407 nm. The developed method has good accuracy and precision. PDAB does not interact with Empagliflozin or Metformin under these optimal conditions. Therefore, this developed method is distinguished by its accuracy and specificity in assaying Linagliptin both alone and in combination drug products.
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