STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALOGLIPTIN BENZOATE AND METFORMIN HYDROCHLORIDE IN TABLET DOSAGE FORM
Objective: A new simple, accurate, precise, economic and robust stability indicating RP-HPLC method has been developed and subsequently validated for the estimation of alogliptin and metformin in bulk and pharmaceutical dosage form.
Methods: The HPLC separation was carried out by using hypersil BDS, C18 (250 x 4.6 mm, 5m.) column with a mobile phase comprising phosphate buffer and acetonitrile (48:52 % v/v) pH adjusted to 4.8 with orthophosphoric acid. The flow rate of the mobile phase was 1.0 ml/min and effluent was monitored at 210 nm using PDA detector. The retention time of alogliptin and metformin was 3.78 min and 2.78 min respectively. Forced degradation studies were conducted to know the stability of the drug samples under various stress conditions like acid, base, peroxide, and photolytic degradation according to ICH guidelines.
Results: The results of this study showed excellent separation of the drug samples using developed method. The percentage recoveries were found 99.91 to 101.01% for alogliptin and 99.78-100.87% for metformin which is in the limits of acceptance. The calibration curve was plotted and the method was found to be linear over a range of 3-18 Âµg/ml and 125â€“750Âµg/ml of alogliptin and metformin respectively and regression data for calibration curve showed good linear relationship with r2= 0.9990 for the both alogliptin and metformin. In the study stability section, it was observed that there is no interference of the degradation products with drug samples.
Conclusion: A new stability-indicating RP-HPLC method has been developed for estimation of alogliptin and metformin in bulk and pharmaceutical dosage form. The developed method was validated, and it was found to be simple, sensitive, precise, robust and it can be used for the routine analysis of alogliptin and metformin in both bulk and pharmaceutical dosage forms.
2. Radha A, Andjela D, Marc R. Algliptin: a new addition to the class of DPP-4 inhibitors. J Diabetes, Metab Syndrome Obesity 2009;2:117-26.
3. Baetta R, Corsisni A. Pharmacology of dipetidy peptidase-4 inhibitors, similarities, and differences. Drugs 2011;71:1441-67.
4. Deacon CF. Dipeptidyl peptidase-4 inhibitors in the treatment of type 2 diabetes: a comparative review. Diabetes Obesity Metab 2011;13:7-18.
5. Baggio LL, Drucker DJ. Biology of incretins: GLP-1 and GIP. Gastroenterology 2007;132:2131-57.
6. Gautier JF, Fetita S, Sobngwi E, Salaun-Martin C. Biological actions of incretins GIP and GLP-1 and therapeutic perceptive in patients with type 2 diabetes. Diabetes Metab 2005;31:233-42.
7. Indian Pharmacopoeia. The government of India, Ministry of health and Family Welfare. The Indian Pharmacopoeia Commission, Ghaziabad 2005;2-3:1657, 2186.
8. Martindale. The Complete Drug Reference: Pharmaceutical Press; 2011. p. 411.
9. Marc F, Bruno G, Bertrand L, Michael P, Benoit V. Metformin: from the mechanism of action to therapies. Cell Metab 2014;20:953-66.
10. Graham R, Ewan RP, Kei S. Molecular mechanism of action of metformin: old or new insights. Diabetologia 2013;56:1898-906.
11. Lilian BR, Marilia B. Metformin: an old but still the best treatment for type 2 diabetes. Diabetol Metab Syndr 2013;5:1-15.
12. Sadhana BT, Mohite SK, Snehal M, Sucheta R. Development and validation of UV spectrophotometric methods for simultaneous estimation of voglibose and metformin hydrochloride in bulk and tablet dosage form. Indo Am J Pharm Res 2013;3:7018-24.
13. Murthy TK, Geethanjali J. Development of a validated RP-HPLC method for simultaneous estimation of metformin hydrochloride and rosuvastatin calcium in bulk and in-house formulation. J Chromatogr Sep-Tech 2014;5:1-7.
14. G Srinivasa R, Mallesh K, Vijay Kumar G, Surekha CH, Venugopala Rao B. A validated chiral HPLC method for the enantiomeric purity of alogliptin benzoate. Der Pharm Chem 2014;6:234-9.
15. Chirag, Amrita P. Development and validation of UV spectrophotometric method for simultaneous estimation of metformin hydrochloride and alogliptin benzoate in bulk drugs and combined dosage forms. Der Pharm Chem 2014;6:303-11.
16. Ramzia I, Ehab FE, Bassam MA. Liquid chromatographic determination of alogliptin in bulk and in its pharmaceutical. Int J Biomed Sci 2012;8:215â€“8.
17. Praveen kumar A, Aruna G. Analytical method development, and validation of alogliptin and metformin hydrochloride tablet dosage form by RP-HPLC method. Int Bull Drug Res 2013;3:58-68.
18. ICH, Q2A Text on Validation of Analytical Procedures, International Conference On Harmonization, Geneva; 1994. p. 1-5.
19. ICH, Stability Testing of New Drug Substances and Products (Q1AR2), International Conference on Harmonization, IFPMA, Geneva; 2003.