Vemula Prathyusha, Dodda Dilip, Balekari Umamahesh, Panga Shyam, Veeresham Ciddi
Department of Pharmaceutical Analysis, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, Telangana, India.
J Adv Pharm Technol Res. 2015 Jan-Mar;6(1):25-8. doi: 10.4103/2231-4040.150368.
To enhance patient compliance toward treatment in diseases like diabetes, usually a combination of drugs is prescribed. Therefore, an anti-diabetic fixed-dose combination of 2.5 mg of linagliptin 500 mg of metformin was taken for simultaneous estimation of both the drugs by reverse phase-high performance liquid chromatography (RP-HPLC) method. The present study aimed to develop a simple and sensitive RP-HPLC method for the simultaneous determination of linagliptin and metformin in pharmaceutical dosage forms. The chromatographic separation was designed and evaluated by using linagliptin and metformin working standard and sample solutions in the linearity range. Chromatographic separation was performed on a C18 column using a mobile phase of 70:30 (v/v) mixture of methanol and 0.05 M potassium dihydrogen orthophosphate (pH adjusted to 4.6 with orthophosphoric acid) delivered at a flow rate of 0.6 mL/min and UV detection at 267 nm. Linagliptin and metformin shown linearity in the range of 2-12 μg/mL and 400-2400 μg/mL respectively with correlation co-efficient of 0.9996 and 0.9989. The resultant findings analyzed for standard deviation (SD) and relative standard deviation to validate the developed method. The retention time of linagliptin and metformin was found to be 6.3 and 4.6 min and separation was complete in <10 min. The method was validated for linearity, accuracy and precision were found to be acceptable over the linearity range of the linagliptin and metformin. The method was found suitable for the routine quantitative analysis of linagliptin and metformin in pharmaceutical dosage forms.
为提高糖尿病等疾病患者对治疗的依从性,通常会开具联合用药处方。因此,采用2.5毫克利格列汀与500毫克二甲双胍的抗糖尿病固定剂量组合,通过反相高效液相色谱法(RP-HPLC)同时测定这两种药物。本研究旨在开发一种简单、灵敏的RP-HPLC方法,用于同时测定药物剂型中的利格列汀和二甲双胍。使用利格列汀和二甲双胍工作标准品及线性范围内的样品溶液进行色谱分离设计和评估。在C18柱上进行色谱分离,流动相为甲醇与0.05 M磷酸二氢钾(用正磷酸调至pH 4.6)按70:30(v/v)混合而成,流速为0.6 mL/min,在267 nm处进行紫外检测。利格列汀和二甲双胍分别在2-12 μg/mL和400-2400 μg/mL范围内呈线性,相关系数分别为0.9996和0.9989。对所得结果分析标准偏差(SD)和相对标准偏差以验证所开发的方法。利格列汀和二甲双胍的保留时间分别为6.3分钟和4.6分钟,分离在<10分钟内完成。该方法经线性验证,在利格列汀和二甲双胍的线性范围内,准确度和精密度均可接受。该方法适用于药物剂型中利格列汀和二甲双胍的常规定量分析。