| Autor: |
Godase, Sameer Narayan, Vikhe, Kavita Bhushan, Kolhe, Mahesh Hari, Mhaske, Shubham Balasaheb, Bhor, Rohit Jaysing, Gawali, Payal Sopan |
| Předmět: |
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| Zdroj: |
International Journal of Pharmaceutical Investigation; Apr-Jun2024, Vol. 14 Issue 2, p585-592, 8p |
| Abstrakt: |
Background: Teneligliptin is a new drug recently approved by FDA for treatment of type 2 Diabetes Mellitus (DMT 2). Very few methods have been reported for analysing its degradation products and their impact on human health. Materials and Methods: A precise, specific, and sensitive gradient UHPLC technique was developed and validated to analyze Teneligliptin using an Agilent C18 column (4.6x100 mm ID) with 2.5 µm particle size. The method employs a flow rate 0.9 mL/min and detects the teneligliptin at a wavelength 241 nm. This method comprises a mobile phase consists a mixture of Methanol with 0.1% TEA (60:40%v/v), along with a 20 µL injection volume for duration of 20 min. Results: Linearity was found in the range of 2-10 µg/mL having a correlation coefficient of 0.999. The retention time for Teneligliptin was found to be 2.382. Furthermore, the precision and robustness of the method were validated with a remarkable RSD (Relative Standard Deviation) below 2%. Conclusion: The method's stability under various stress conditions was confirmed through forced degradation studies conducted on both bulk substances and pharmaceutical dosage forms. Validation of the method followed the guidelines outlined by the ICH for assessing the validation parameters like specificity, linearity, accuracy, precision, robustness, LOQ and LOD. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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