Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry


Stability Indicating Method Development and Validation for Simultaneous Estimation of Linagliptin and Metformin HCl in Tablets by HPLC

Author(s): Nagunath Sirigiri, Siva Subramanian N, Naveen Kumar Reddy G

An accurate, simple, new, precise, rugged and stability indicating method was developed for simultaneous estimation of linagliptin and metformin HCl in tablets. The developed method was rapid and economic. The Chromatographic separation was achieved isocratically on a C- 18 column by utilizing di-ammonium hydrogen phosphate buffer: ACN: MeOH (60:20:20 v/v/v) at the flow rate of 1 ml/min with UV detection at 272 nm. The retention times of linagliptin and metformin are 3.180 min and 6.120 min respectively. The method is linear within range 1.25 μg/ml to 10 μg/ml for linagliptin and 250 μg/ml to 2000 μg/ml for Metformin. The correlation coefficient was found to be R2=0.999 and 1.0 for linagliptin and metformin respectively. Both standard and test solutions proved to be stable for up to 48 h. Forced degradation study showed that the method is stability indicating. The developed method can be used for routine analysis of linagliptin and metformin fixed dose combination.