Stability Indicating RP-HPLC-DAD Method For Simultaneous Estimation of Atorvastatin Calcium and Teneligliptin Hydrobromide Hydrate in Synthetic Mixture

Analytical Chemistry Letters Pub Date : 2022-09-03 DOI:10.1080/22297928.2022.2131467

Urvi Chotaliya, Hiteksha J. Dobariya, Disha L. Barad, A. Vyas, Dhruvanshi Gol

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引用次数: 2

Abstract

Abstract RP-HPLC stability indicating specific, precise, accurate, cost-effective and isocratic method was developed and validated for quantitative analysis of Atorvastatin calcium and Teneligliptin hydrobromide hydrate in synthetic mixture with presence of its degradants. Separation was achieved by using Gemini, C18, using mobile phase composition [Methanol: 20 mM Ammonium acetate (70:30 v/v)] using a flow rate of 1.0 ml/min, injection volume 10µl with UV detection at 245 nm. Atorvastatin calcium and Teneligliptin hydrobromide hydrate were eluted with retention time 7.47min and 4.74min respectively. This method was validated as per ICH guideline Q2(R1). The calibration plots were over the concentration range of 10-100 μg/ml and 5-50 μg/ml for Atorvastatin calcium and Teneligliptin hydrobromide hydrate with correlation coefficient 1 and 0.9999 respectively. Percentage recovery was obtained between 98.00-100.51 % and 98.90-100.7 % for Atorvastatin calcium and Teneligliptin hydrobromide hydrate respectively. In case of Precision, Repeatability and Robustness RSD should be found less than 2. LOD were found to be 1.22 μg/ml and 0.54 μg/ml and LOQ were found to be 3.70 μg/ml and 1.64 μg/ml for Atorvastatin calcium and Teneligliptin hydrobromide hydrate respectively. The results showed that the developed method is appropriate for the routine analysis of Atorvastatin calcium and Teneligliptin hydrobromide hydrate in a synthetic mixture in presence of its degradants. GRAPHICAL ABSTRACT

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稳定性指示RP-HPLC-DAD法同时测定合成混合物中阿托伐他汀钙和水合物替尼格列汀的含量

摘要建立了一种稳定性良好的RP-HPLC方法，该方法具有特异性、精密度、准确性、成本效益和等密度，可用于合成混合物中阿托伐他汀钙和水合氢溴替尼格列汀的定量分析。采用Gemini, C18进行分离，流动相为[甲醇:20 mM乙酸铵(70:30 v/v)]，流速为1.0 ml/min，进样量为10µl，紫外检测波长为245 nm。阿托伐他汀钙和水合物氢溴化替尼格列汀洗脱，保留时间分别为7.47min和4.74min。该方法按照ICH指南Q2(R1)进行验证。阿托伐他汀钙和水合氢溴酸替尼格列汀的浓度范围分别为10 ~ 100 μg/ml和5 ~ 50 μg/ml，相关系数分别为1和0.9999。阿托伐他汀钙和氢溴化替尼格列汀的回收率分别为98.00 ~ 100.51%和98.90 ~ 100.7%。在精密度、重复性和稳健性方面，RSD应小于2。阿托伐他汀钙和氢溴化替尼格列汀的定量限分别为1.22和0.54 μg/ml，定量限分别为3.70和1.64 μg/ml。结果表明，该方法适用于有降解物存在的合成混合物中阿托伐他汀钙和氢溴化替尼格列汀的常规分析。图形抽象

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来源期刊

Analytical Chemistry Letters

CiteScore

2.30

自引率

0.00%

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