Spectrophotometric estimation of linagliptin using ion-pair complexation and oxidative coupling reactions – A Green Approach
Abstract
Background: Two specific spectrophotometric methods (visible region) have been established using water as a solvent and validated for the analysis of linagliptin in API and pharmaceutical dosage forms.
Methods: Method-A is established on the computation of the absorbance of green-colored chromogen complex at 660 nm, which is formed by the oxidative coupling reaction of linagliptin with MBTH (3-methyl-2-benzothiazoline hydrazine) in the presence of ferric chloride. Method-B is established on the computation of the absorbance of an orange-colored ion-pair chromogen at 490 nm, which is formed by the charge transfer reaction of the primary amino group of linagliptin with picric acid.
Results: Beer's law is obeyed in the drug concentration range of 2-12 µg/mL and 1-25 µg/mL for methods A and B, respectively with a correlation coefficient of 0.999. The contemplated methods are validated statistically according to ICH Q2(R1) guidelines and results are found to be within the acceptable limits. The labeled amount of linagliptin in a marketed formulation (TRAJENTA®) is determined without interference owed to excipients. Conclusion: The contemplated green approached spectrophotometric methods can prolifically be employed for analysis of linagliptin because of its easy access in most quality control laboratories.
Methods: Method-A is established on the computation of the absorbance of green-colored chromogen complex at 660 nm, which is formed by the oxidative coupling reaction of linagliptin with MBTH (3-methyl-2-benzothiazoline hydrazine) in the presence of ferric chloride. Method-B is established on the computation of the absorbance of an orange-colored ion-pair chromogen at 490 nm, which is formed by the charge transfer reaction of the primary amino group of linagliptin with picric acid.
Results: Beer's law is obeyed in the drug concentration range of 2-12 µg/mL and 1-25 µg/mL for methods A and B, respectively with a correlation coefficient of 0.999. The contemplated methods are validated statistically according to ICH Q2(R1) guidelines and results are found to be within the acceptable limits. The labeled amount of linagliptin in a marketed formulation (TRAJENTA®) is determined without interference owed to excipients. Conclusion: The contemplated green approached spectrophotometric methods can prolifically be employed for analysis of linagliptin because of its easy access in most quality control laboratories.
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