title: Simultaneous determination of linagliptin and metformin by reverse phase-high performance liquid chromatography method: An application in quantitative analysis of pharmaceutical dosage forms.
abstract: To enhance patient compliance toward treatment in diseases like diabetes, usually a combination of drugs is prescribed. Therefore, an anti-diabetic fixed-dose combination of 2.5 mg of linagliptin 500 mg of metformin was taken for simultaneous estimation of both the drugs by reverse phase-high performance liquid chromatography (RP-HPLC) method. The present study aimed to develop a simple and sensitive RP-HPLC method for the simultaneous determination of linagliptin and metformin in pharmaceutical dosage forms. The chromatographic separation was designed and evaluated by using linagliptin and metformin working standard and sample solutions in the linearity range. Chromatographic separation was performed on a C18 column using a mobile phase of 70:30 (v/v) mixture of methanol and 0.05 M potassium dihydrogen orthophosphate (pH adjusted to 4.6 with orthophosphoric acid) delivered at a flow rate of 0.6 mL/min and UV detection at 267 nm. Linagliptin and metformin shown linearity in the range of 2-12 μg/mL and 400-2400 μg/mL respectively with correlation co-efficient of 0.9996 and 0.9989. The resultant findings analyzed for standard deviation (SD) and relative standard deviation to validate the developed method. The retention time of linagliptin and metformin was found to be 6.3 and 4.6 min and separation was complete in <10 min. The method was validated for linearity, accuracy and precision were found to be acceptable over the linearity range of the linagliptin and metformin. The method was found suitable for the routine quantitative analysis of linagliptin and metformin in pharmaceutical dosage forms.
authors.affiliation: Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Telangana, India.
authors.forename: Prathyusha
authors.initials: P
authors.lastname: Vemula
authors.affiliation: Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Telangana, India.
authors.forename: Dilip
authors.initials: D
authors.lastname: Dodda
authors.affiliation: Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Telangana, India.
authors.forename: Umamahesh
authors.initials: U
authors.lastname: Balekari
authors.affiliation: Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Telangana, India.
authors.forename: Shyam
authors.initials: S
authors.lastname: Panga
authors.affiliation: Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Telangana, India.
authors.forename: Ciddi
authors.initials: C
authors.lastname: Veeresham
keywords: Linagliptin; metformin; reverse phase-high performance liquid chromatography