ABSTRACT

A sensitive, exact, rapid and robust HPLC method was developed for the quantification of Teneligliptin (TG) with UV detector. In this method, a reversed-phase Grace C18 (250mm x 4.6ID, Particle size: 5 micron) column with a mobile phase of methanol: 0.05% OPA (20:80; v/v) at 0.8ml/min flow rate was used to separate TG with a detection of 249nm. The volume injected was 20 µL. The retention time of TG was obtained as 5.255 min. All necessary validation parameters and system suitability tests were carried out in details. The analytical curve was linear (r2 = 0.999) over a wide concentration range (10-50 µg/ml). The system shows adequate accuracy with relative standard deviation less than 2.0%. The method showed good duplicability and recovery with % RSD less than 2%. So, the proposed system was found to be simple, specific, precise, accuracy, linear, and rugged. Hence it can be applied for practice analysis of Teneligliptin (TG) in bulk drug. Keywords: RP-HPLC estimation, Method development, Validation, Teneligliptin
Publication date: 01/10/2021

https://ijbpas.com/pdf/2021/October/MS_IJBPAS_2021_OCT_SPCL_1010.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.10.1010