A new and simple method was developed for quantitative determination of Linagliptin (LINA) and Metformin (MET) spiked with plasma using an Onyx C18 Monolithic column connected with an Onyx C18 guard cartridge and PDA detection at 220 nm. The optimized mobile phase acetonitrile (ACN), methanol (MeOH), formic acid (HCOOH) was pumped at 0.892 mL/min. The method was linear between 0.02-0.1 µg/mL, statistically validated for its linearity, precision, and accuracy. The precision was found to be less than 1% in the assay method. It was found that the additives in the commercial tablet did not interfere with the method. The currently developed method can routinely use for the estimation of LINA and MET related compounds from the tablet dosage form spiked with plasma.
This is a collective data for Linagliptin from previously published methods either in alone or in combination with Metformin or Empagliflozine . Many spectroscopic methods like derivative techniques, chromogenic techniques were used for newly developed as well as improved chromatographic methods were reported for biological fluids and pharmaceutical formulations. Apart from these two techniques few LC-MS/MS and HPTLC methods also available. Now in this present
analytical research world quality by design or design by expert technique is used to get improved method for method validation. This concise review work can guide an analyst to choose most appropriate method for a best analytical method
development and validation of Linagliptin alone or in combination with Metformin or Empagliflozine.
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