Vetapalem Rajani, Yejella Rajendra Prasad, Atmakuri Lakshmana Rao
Acharya Nagarjuna University, Department of Biotechnology, Nagarjuna Nagar, India.
University College of Pharmaceutical Sciences, Department of Pharmaceutical Chemistry, Andhra University, Visakhapatnam, India.
Turk J Pharm Sci. 2020 Apr;17(2):141-147. doi: 10.4274/tjps.galenos.2018.16768. Epub 2020 Apr 24.
The main objective of the present work is to develop a simple, precise, specific and stability method indicating reverse phase high performance liquid chromatography method for simultaneous estimation of teneligliptin and metformin in bulk and tablet dosage form.
The analysis was performed with a Kromasil C18 column (250×4.6 mm, 5 μm) at 30°C using buffer: acetonitrile: methanol (65:25:10, v/v/v) as mobile phase. The detection was carried out with a flow rate of 1.0 mL/min at 254 nm.
The retention time of teneligliptin and metformin was 2.842 min and 2.017 min, respectively. The linearity range was 5-30 μg/mL for teneligliptin and 125-750 μg/mL for metformin. The forced degradation studies were performed as per the guidelines of the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use under acidic, alkaline, oxidative, thermal, photostability, and neutral conditions.
This method was successfully validated for all the parameters and could detect the the correct amounts of active drug substance in formulations that are available in the market. This developed method in the present study could be successfully employed for the simultaneous estimation of teneligliptin and metformin in bulk and tablet dosage form.
本研究的主要目的是开发一种简单、精确、特异且稳定的反相高效液相色谱法，用于同时测定替格列汀和二甲双胍原料药及片剂剂型中的含量。
分析采用Kromasil C18柱（250×4.6 mm，5μm），在30℃下，以缓冲液：乙腈：甲醇（65:25:10，v/v/v）作为流动相。检测在254 nm波长下，流速为1.0 mL/min的条件下进行。
替格列汀和二甲双胍的保留时间分别为2.842分钟和2.017分钟。替格列汀的线性范围为5 - 30μg/mL，二甲双胍的线性范围为125 - 750μg/mL。按照人用药品技术要求国际协调理事会的指导原则，在酸性、碱性、氧化、热、光稳定性和中性条件下进行了强制降解研究。
该方法的所有参数均成功得到验证，能够检测市售制剂中活性药物成分的正确含量。本研究中开发的方法可成功用于同时测定替格列汀和二甲双胍原料药及片剂剂型中的含量。
