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

Santosh R Butle 1  ,  
 
1
School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded
2
School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded-431 606
3
AISSMS College of Pharmacy, Kennedy Road, Near RTO, Pune-411001
Eurasian J Anal Chem 2017;12(4)
Publish date: 2016-12-28
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ABSTRACT:
Background:
The present work describes development and validation of a new simple, accurate, precise and selective stability- indicating 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 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.

Material and methods:
ALGP was kindly supplied by Getz Pharma Research Pvt. Ltd., Ambarnath, Thane, India). The pharmaceutical dosage form used in this study was NESINA tablets

Results:
Mobile phase:Benzene: Ethyl acetate: Triethylamine (7.5: 2: 0.5, v/v/v) was selected as optimal for obtaining well defined and resolved peak. The retention factor for ALGP was found to be 0.62 ± 0.10. The results obtained showed no interference or merging with any drug peak indicating the specificity of the method.

Conclusions:
A simple, precise, accurate, reproducible, and stability-indicating HPTLC method without interference from the excipients or from degradation products has been developed and validated for the determination of ALGP

CORRESPONDING AUTHOR:
Santosh R Butle   
School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded, School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded, 431 606 Nanded, India
eISSN:1306-3057