0.60
CiteScore
0.186
SJR
0.447
SNIP
CC-BY 4.0
 
 

Stability Indicating High Performance Thin Layer Chromatographic Determination of Alogliptin Benzoate as Bulk Drug and in Tablet Dosage Form

 
1
AISSMS College of Pharmacy, Kennedy Road, Near RTO, Pune-411001, INDIA
2
School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded-431 606, INDIA
Eurasian J Anal Chem 2017;12(4):325–335
Online publish date: 2016-12-28
Publish date: 2016-12-28
KEYWORDS:
TOPICS:
ABSTRACT:
Alogliptin Benzoate is a novel hypoglycemic drug that belongs to dipeptidylpeptidase-4 inhibitor class which stimulates glucose-dependent insulin release. The present work describes development and validation of a new simple, accurate, precise and selective stability- indicating high performance thin layer chromatographic (HPTLC) method for determination of Alogliptin Benzoate in tablet dosage form. The chromatographic separation was achieved by using Benzene: Ethyl acetate: Triethylamine (7.5: 2: 0.5, v/v/v) as mobile phase and UV detection at 222 nm. The retention factor for Alogliptin Benzoate was found to be 0.62 ± 0.10. The developed method was validated with respect to linearity, accuracy, precision, limit of detection, limit of quantitation and robustness as per ICH guidelines. The drug was subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. Results found to be linear in the concentration range of 250-1500 ng band-1. The method has been successfully applied for the estimation of drug in tablet dosage form. The % assay (Mean ± S.D.) was found to be 99.56 ± 1.15. The developed method can be used for the quantification of drug in the dosage form, bulk drug as well as for routine analysis in quality control laboratories.
CORRESPONDING AUTHOR:
Santosh R. Butle   
School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded-431 606, MH, India
 
REFERENCES (23):
1. https://en.wikipedia.org/wiki/Alogliptin (accessed on 11/06/2015).
2. Zhang, K., Panqin, M., Wenna, J., & Zhang, X. (2015). A developed HPLC method for the determination of alogliptin benzoate & its potential impurities in bulk drug and tablets. Asian Journal of Pharmaceutical Sciences, 10, 152-158.
3. Ramzia, I. E., Ehab, F. E., & Bassam, M. A. (2012). Liquid chromatographic determination of alogliptin in bulk and in its pharmaceutical preparation. International Journal of Biomedical Science, 8, 215-218.
4. Srinivasa Rao, G., Mallesh, K., Vijay Kumar, G., Surekha, C. & Venugopala Rao, B. (2014). A validated chiral HPLC method for the enantiomeric purity of alogliptin benzoate. Der Pharma Chemica, 6, 234-239.
5. Yadav, P. J., Jadhav, S. S., & Mohite, S. K. (2014). Development and validation of RP-HPLC method for alogliptin benzoate in bulk drug and dosage form. International Journal of Pharmacy and Pharmaceutical Research, 1, 1-9.
6. Praveen Kumar, A., Aruna, G., Rajasekar, K. & Jayachandra Reddy, P. (2013). Analytical method development and validation of alogliptin and metformin hydrochloride tablet dosage form by RP-HPLC method. International Bulletin of Drug Research, 3, 58-68.
7. Satya Sri, G., Ashutosh Kumar, S., Saravanan, J., Debnath, M., Greeshma, V., & Sai Krishna, N. (2013). A new RP-HPLC method development and validation for simultaneous estimation of metformin and alogliptin in bulk as well as in pharmaceutical formulation by using PDA detector. World Journal of Pharmacy and Pharmaceutical Sciences, 2, 6720-6743.
8. Manzoor, A., Anusha, M., Satishkumar, S. A., Kuppast, I. J., Siddalingaswamy, M. S., & Ravi, M. C. (2014). RP-HPLC method development and validation for simultaneous estimation of alogliptin and pioglitazone in combined tablet dosage form. World Journal of Pharmacy and Pharmaceutical Sciences, 4, 863-874.
9. Thangabalan, B., Sri Sowmya, P., & Manohar Babu, S. (2014). Method development and validation for metformin hydrochloride and alogliptin in bulk and pharmaceutical formulation by RP-HPLC method. International Journal of Innovative Pharmaceutical Sciences and Research, 2, 1451-1464.
10. Koduru, S., Kalepu, S., & Mitta, C. (2015). Method development for the simultaneous estimation of metformin and alogliptin by using RP-HPLC. International Journal of Pharma Research and Health Sciences, 3, 747-753.
11. Satya Sri, G., Ashutosh Kumar, S., Saravanan, J., Debnath, M., Greeshma, V., & Sai Krishna, N. (2013). A new stability indicating RP-HPLC method development for simultaneous estimation of metformin and alogliptin in bulk as well as in pharmaceutical formulation by using PDA detector. Indo American Journal of Pharmaceutical Research, 3, 9222-9241.
12. Neelima, B., Ravi Kumar, P., Hima Bindu, V., & Rajendra Prasad, Y. (2014). A validated stability indicating RP-HPLC method for simultaneous determination of alogliptin and pioglitazone in bulk and pharmaceutical formulations. International Journal of Pharmacy, 4, 458-464.
13. Ashutosh, K. S., Manidipa, D., Seshagiri, R. J. V. L. N., & Gowri, S. D. (2015). New validated stability indicating RP-HPLC method for simultaneous estimation of metformin and alogliptin in human plasma. Journal of Chromatography and Separation Techniques, 6, 1-6.
14. Chirag and Parle, A. (2014). Development and validation of UV spectrophotometric method for simultaneous estimation of metformin hydrochloride and alogliptin benzoate in bulk drugs and combined dosage forms. Der Pharma Chemica, 6, 303-311.
15. Sen, D. B., Sen, A., Zanwar, A., Balaraman, R., & Seth, A. K. (2015). Determination of alogliptin benzoate and metformin hydrochloride in tablet dosage form by simultaneous equation and absorption ratio method. International Journal of Pharmacy and Pharmaceutical Sciences, 7, 380-383.
16. Kashyap, R., & Srinivasa, U. (2014). First order derivative and dual wavelength spectrophotometry methods development and validation for simultaneous estimation of alogliptin and pioglitazone in bulk and dosage form. International Journal of Pharmacy and Pharmaceutical Sciences, 6, 730-738.
17. Pavan Kumar, H. K., Manzoor, A., Satishkumar Shetty, A., & Aradhya, V. K. (2014). UV visible spectrophotometric method for simultaneous estimation of alogliptin benzoate and metformin hydrochloride in combine tablet dosage form. International Journal of Universal Pharmacy and Bio Sciences, 3, 337-349.
18. Anusha, M., Manzoor, A., Satishkumar Shetty, A., & Aradhya, V. K. (2014). Simultaneous estimation of alogliptin and pioglitazone in bulk and combined tablet dosage form by UV spectrophotometric methods. International Journal of Universal Pharmacy and Bio Sciences, 3, 364-376.
19. Sharma, K., & Parle, A. (2015). Development and validation of HPTLC method for Estimation of alogliptin benzoate in bulk drugs and tablet dosage forms. International Bulletin of Drug Research, 5, 81-89.
20. Sharma, K., Parle, A., & Sayeed, A. (2015). Development and validation of HPTLC method for simultaneous estimation of metformin hydrochloride and alogliptin benzoate in bulk drugs and combined dosage forms. Der Pharmacia Lettre, 7, 321-328.
21. Sharma, K., & Parle, A. (2015). Development and validation of HPTLC method for simultaneous estimation of alogliptin benzoate and pioglitazone hydrochloride in bulk drugs and combined dosage forms. International Journal of Pharma Research & Review, 4, 35-42.
22. International Conference on Harmonization (2005) ICH harmonised tripartite guideline Validation of analytical procedures, text and methodology Q2 (R1) ICH, Geneva, Nov (2005).
23. International Conference on Harmonization (ICH), Stability testing of new drug substances and products, Q1A (R2), (2003).
eISSN:1306-3057