Development and validation of spectrophotometric method for the determination of dpp4 inhibitor, sitagliptin, in its pharmaceutical dosage forms

International Journal of Pharmacy and Pharmaceutical Sciences

Volumn 2, Issue 4, 2010, Pages 138-142

  Bala Sekaran, C ^a   Prameela Rani, A ^b  

^a Jagarlamudi Kuppuswamy Choudary College   (India)

^b NIRMALA COLLEGE OF PHARMACY   (India)

Author keywords

Acetyl acetone; Beer's law; Sandell's sensitivity; Sitagliptin phosphate

Indexed keywords

SITAGLIPTIN;

ARTICLE; DRUG ABSORPTION; DRUG DETERMINATION; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG STRUCTURE; DRUG SYNTHESIS; PROCESS DEVELOPMENT; SENSITIVITY ANALYSIS; SPECTROPHOTOMETRY; VALIDATION PROCESS;

EID: 79953000741     PISSN: None     EISSN: 09751491     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

1. Herman G, Stevens C, Van Dyck K, Bergman A, Yi B, De Smet M, et al. Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses. Clin Pharmacol Ther 2005; 78: 675-688.
2. Januvia Side Effects & Drug Interactions. RxList.com, 2007. 3. U.S. Food and Drug Administration. FDA Approves New Treatment for Diabetes. 2006.
3. Herman G, Bergman A, Liu F, Stevens C, Wang A, Zeng W, et al. Pharmacokinetics and pharmacodynamic effects of the oral DPP-4 inhibitor sitagliptin in middle-aged obese subjects. J Clin Pharmacol 2006; 46: 876-886.
4. Stella Vincent H, James Reed R, Bergman AJ, Elmore CS, et al. Metabolism and excretion of dipeptidase 4 inhibitor (14C) sitagliptin in humans. Drug Metab Dispos 2007; 35: 533-538.
5. Wei Zeng, Donald G Musson, Alison L Fisher, Li Chen, Michael S Schwartz, Eric J Woolf & Amy Qiu Wang. Determination of sitagliptin in human urine and hemodialysate using turbulent flow online extraction and tendem mass spectrophotometry. J Pharmaceut Biomed 2008; 46: 534-542.
6. Ramakrishna Nirogi, Vishwottam Kandikere, Koteshwara Mudigonda, Prashanth Komarneni, Raghupathi Aleti & Rajeshkumar Boggavarapu. Sensitive liquid chromatography tandem mass spectrometry method for the quantification of sitagliptin, a DPP-4 inhibitor, in human plasma using liquidliquid extraction. Biomed Chromatogr 2008; 22: 214-222.
7. Beconi MG, Reed JR, Yohannes Teffera, Yuan-Qing Xia, Kochansky CJ, Liu D Q, et al. Disposition of the Dipeptidyl Peptidase 4 Inhibitor Sitagliptin in Rats and Dogs. Drug Metab Dispos 2007; 35: 525-532.
8. Derker Bratlon FRS and David Olis W. "Comprehensive Organic Chemistry", The Synthesis and Reactions of Organic Compounds 4. London: Pergamon Press; 1979.
9. Amin AS and Zareh MM. Acetylacetone-formaldehyde reagent for the spectrophotometric determination of some sulfa drugs in pure and dosage forms. Microchim Acta 1996; 124: 227-233.
10. Ahmad AS, Hoda NMD, Ahmad M, Islam F and Qureshi SZ. A simple and selective kinetic spectrophotometric method for the determination of kanamycin using acetylacetone-formaldehyde reagent in N,N′-dimethylformamide medium. J Anal Chem 2006; 61: 870-874.
11. Fawzy El-Yazbi A, Abdine HH and Shaalan RA. Spectrophotometric and spectrofluorometric methods for the assay of lisinopril in single and multicomponent pharmaceutical dosage forms. J Pharmaceut Biomed 1999; 19: 819-827.
12. Ayad MM, El-Henawee MM, Abdellatef HE and El-Sayed HM. Spectrophotometric and Spectrofluorimetric Determination of Gabapentin and Cefprozil Monohydrate Using Acetylacetone and Formaldehyde. Alex J Pharm Sci 2005; 9: 157-161.
13. Khalifa Abulghasem El-Aroud, Adel Mohamed Abushoffa and Hisham Ezzat Abdellatef. Spectrophotometric and Spectrofluorimetric Methods for the Determination of Tranexamic Acid in Pharmaceutical Formulation. Chem Pharm Bull 2007; 55: 364-367.
14. Analytical Methods Committee, 1987, Recommendations for the definition, estimation and use of the detection limit. Analyst, 1987.