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Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and Spectrophotometric Method

Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and... AbstractA simple, accurate, precise and economical HPTLC and UV method has been developed and validated for the estimation of teneligliptin hydrobromide hydrate (THH) in bulk and tablet dosage form. The chromatographic method employed pre-coated silica gel 60F254 plates using toluene: methanol: triethylamine (8:2:0.2 v/v/v) as mobile phase. The plates were developed to a distance of 8.0 cm at ambient temperature. Experimental conditions such as band size, chamber saturation time, migration of solvent front, slit width, etc were critically studied and the optimum conditions were selected. A TLC scanner set at 254 nm was used for direct evaluation of the chromatograms in reflectance/absorbance mode. The system was found to give good result for Teneligliptin at Rf 0.51. The calibration plot was found linear between concentration range 0.5-3 μg/ band and r2 = 0.9993. Method was validated according to the ICH guidelines. In stability testing, teneligliptin was found susceptible to alkali hydrolysis and oxidatative degradation. Because the method could effectively separate the drug from its degradation products, it can be used as a stability indicating method. A UV spectrophotometric method was also developed using methanol as solvent at λ max 247 nm. Beer's law was obeyed in the concentration range of 5-50 μg/ml and r2 = 0.9997. The proposed method was validated according to the ICH guidelines. Therefore, both the methods and stress degradation study can be used for routine quality control analysis of Teneligliptin in bulk and pharmaceutical formulation. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and Spectrophotometric Method

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Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and Spectrophotometric Method

Abstract

AbstractA simple, accurate, precise and economical HPTLC and UV method has been developed and validated for the estimation of teneligliptin hydrobromide hydrate (THH) in bulk and tablet dosage form. The chromatographic method employed pre-coated silica gel 60F254 plates using toluene: methanol: triethylamine (8:2:0.2 v/v/v) as mobile phase. The plates were developed to a distance of 8.0 cm at ambient temperature. Experimental conditions such as band size, chamber saturation time, migration of...
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Publisher
Taylor & Francis
Copyright
© 2017 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2017.1364664
Publisher site
See Article on Publisher Site

Abstract

AbstractA simple, accurate, precise and economical HPTLC and UV method has been developed and validated for the estimation of teneligliptin hydrobromide hydrate (THH) in bulk and tablet dosage form. The chromatographic method employed pre-coated silica gel 60F254 plates using toluene: methanol: triethylamine (8:2:0.2 v/v/v) as mobile phase. The plates were developed to a distance of 8.0 cm at ambient temperature. Experimental conditions such as band size, chamber saturation time, migration of solvent front, slit width, etc were critically studied and the optimum conditions were selected. A TLC scanner set at 254 nm was used for direct evaluation of the chromatograms in reflectance/absorbance mode. The system was found to give good result for Teneligliptin at Rf 0.51. The calibration plot was found linear between concentration range 0.5-3 μg/ band and r2 = 0.9993. Method was validated according to the ICH guidelines. In stability testing, teneligliptin was found susceptible to alkali hydrolysis and oxidatative degradation. Because the method could effectively separate the drug from its degradation products, it can be used as a stability indicating method. A UV spectrophotometric method was also developed using methanol as solvent at λ max 247 nm. Beer's law was obeyed in the concentration range of 5-50 μg/ml and r2 = 0.9997. The proposed method was validated according to the ICH guidelines. Therefore, both the methods and stress degradation study can be used for routine quality control analysis of Teneligliptin in bulk and pharmaceutical formulation.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Jul 4, 2017

Keywords: Teneligliptin hydrobromide; HPTLC; spectroscopic method; validation; forced degradation

References

  • Teneligliptin: a DPP-4 inhibitor for the treatment of type 2 diabetes
  • Recent approaches to medicinal chemistry and therapeutic potential of dipeptidyl peptidase-4 (DPP-4) inhibitors
  • Teneligliptin as an initial therapy for newly diagnosed, drug native subjects with type II diabetes
  • A simple uv- spectrophotometric method development and validation of teneligliptin in tablet dosage form
  • Stability indicating rp-HPLC method for development and validation of teneligliptin hydrobromide hydrate in pure and tablet dosage forms
  • Development and validation of LC-MS/MS method for quantification of teneligliptin in human plasma and its application to a pharmacokinetic study
  • A Simple and Sensitive HPTLC Method for Simultaneous Analysis of Phenylephrine hydrochloride and Ketorolac tromethamine in Combined Dose Formulation
  • Stability indicating HPTLC method for estimation of Dexibuprofen in pharmaceutical dosage form
  • Stability indicating HPTLC method for estimation of Lomefloxacin Hydrochloride in pharmaceutical dosage form