Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 4 Issue 3

Development and Validation of New Spectrophototmetric Methods for the Determination of Sitagliptin

Gunuputi Sushma, Duggirala Sri Harsha and Mukthinuthalapati Mathrusri Annapurna*

GITAM Institute of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam, India

*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, GITAM Institute of Pharmacy, GITAM (Deemed to be) University, Visakhapatnam, India.

Received: February 27, 2020; Published: February 28, 2020

×

Abstract

  Sitagliptin is a novel oral hypoglycemic drug of dipeptidyl peptidase-4 inhibitor class. Dipeptidyl peptidase-4 inhibitors represent a new therapeutic approach for the treatment of type 2 diabetes that functions to stimulate glucose-dependent insulin release and reduce glucagons levels. This is done through inhibition of the inactivation of incretins, particularly glucagon-like peptide-1 and gastric inhibitory polypeptide), thereby improving glycemic control. Five new spectrophotometric methods have been established for the determination of Sitagliptin tablets. SHIMADZU Model No. UV – 1800 double beam spectrophotometer with quartz cells was used for the proposed study Sitagliptin has shown absorption maxima at 267 nm in reagents such as phosphate buffers (pH 5.0 and 8.0), acetate buffer (pH 4.7), 0.1N NaOH and borate buffer (pH 9.0) Sitagliptin obeys Beer-Lambert’s law over the concentration range 5 - 100 µg/ml for all the above mentioned methods and all the methods were validated as per ICH guidelines. The methods are simple, precise, accurate and economical and can be used for the quantification of Sitagliptin tablets.

Keywords: Sitagliptin; Spectroscopy; Phosphate Buffer; Borate Buffer; Acetate Buffer; Sodium Hydroxide; Validation

×

References

  1. Ahren B. “What mediates the benefits associated with dipeptidyl peptidase-IV inhibition?” Diabetologia 48 (2005): 605-607. 
  2. Ahren B., et al. “Beta-cell expression of a dominant-negative HNF-1alpha compromises the ability of inhibition of dipeptidyl peptidase-4 to elicit a long-term augmentation of insulin secretion in mice”. European Journal of Pharmacology 521 (2005): 164-168. 
  3. Aschner P., et al. “Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes”. Diabetes Care 29 (2006c): 2632-2637. 
  4. Deacon CF., et al. “Dipeptidyl peptidase IV inhibition as an approach to the treatment and prevention of type 2 diabetes: a historical perspective”. Biochemical and Biophysical Research Communications 294 (2002): 1-4. 
  5. Ravisankar P., et al. “A simple validated UV Spectrophotometric method for quantitative analysis of Sitagliptin phosphate in pharmaceutical dosage form”. Journal of Chemical and Pharmaceutical Sciences 7.3 (2014): 254-258.
  6. Jain Pritam., et al. “Development and validation of first order derivative UV-Spectrophotometric method for determination of Sitagliptin in bulk and in Formulation”. International Journal of Drug Development and Research 3.4 (2011): 194-199.
  7. Maste Meenaxi M., et al. “Spectrophotometric method for estimation of Sitagliptin phosphate in bulk and tablet dosage form”. International Journal of Pharmaceutical Formulation and Analysis 2.2 (2011): 47-50.
  8. Vinit Chavhan and Atul Kadam “UV Spectrophotometric method development and validation for estimation of Sitagliptin phosphate in bulk and tablet dosage Formby absorption ratio and area under the curve method”. Journal of Biological and Scientific opinion 1.4 (2013): 317-322.
  9. Parag Pathade., et al. “Development and validation of stability indicating UV spectrophotometric method for the estimation of Sitagliptin phosphate in bulk and tablet dosage form”. Journal of Pharmacy Research 4.3 (2011): 871-873.
  10. Jeyabalan G and Narendra N. “Analytical method development and validation of Sitagliptine phosphate monohydrate in pure and tablet dosage form by derivative spectroscopy”. Journal of Applied Pharmaceutical Science 3.1 (2013): 95-98.
  11. Jalkote RN and Kalshetti MS. “UV Spectrophotometric method development and validation for determination of Sitagliptin in API and in pharmaceutical dosage form”. World Journal of Pharmacy and Pharmaceutical Sciences 8.5 (2019): 916-925. 
  12. Patil Sachin., et al. “Validated UV spectrophotometric method for estimation of Sitagliptin phosphate in tablet dosage form”. Research Journal of Pharmacy and Technology 3.3 (2010): 798-800.  
  13. Saad Antakli., et al. “Spectrophotometric determination of Sitagliptin in tablets formulations”. Asian Journal of Chemistry 27.1 (2015): 375-378.
  14. Bala Sekaran C and Prameela Rani A. “Development and validation of spectrophotometric method for the determination of DPP-4 inhibitor, Sitagliptin, in its pharmaceutical preparations”. Eclética Química 35.3 (2010): 45-53.
  15. Deepanjali Mohanty., et al. “Extractive spectrophotometric estimation of Sitagliptin phosphate”. International Journal of ChemTech Research 10.4 (2017): 255-263.
  16. Disha NS and Gurupadhayya BM. “Spectrophotometric determination of Sitagliptin Phosphate in bulk and pharmaceutical formulations”. International Journal of Innovative Science, Engineering and Technology 2.7 (2015): 702-709.
  17. Tarkase KN., et al. “Development and validation of UV spectrophotometric method for estimation of Sitagliptin phosphate”. Der Pharmacia Lettre 5.3 (2013):315-318.
  18. Namratha Sunkara., et al. “UV spectrophotometric method development and validation of Sitagliptin in bulk and pharmaceutical dosage form”. International Journal of Pharma and Chemical Research 3.3 (2017): 577-580.
  19. Anudeepa J., et al. “Development of UV‐Spectrophotometric method for Sitagliptin in bulk and pharmaceutical formulation”. International Journal of Science, Engineering and Technology 3.5 (2015): 1352-1354. 
  20. ICH Q2 [R1] validation of analytical procedures: Text and Methodology: November (2005). 
×

Citation

Citation: Mukthinuthalapati Mathrusri Annapurna., et al. “Development and Validation of New Spectrophototmetric Methods for the Determination of Sitagliptin".Acta Scientific Pharmaceutical Sciences 4.3 (2020): 56-60.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


  • Certification for Review
    Acta Scientific certifies the Editors/reviewers for their review done towards the assigned articles of the respective journals.

Contact US