A Validated Method Developed for Estimation of Lifitegrast in Bulk and Pharmaceutical Dosage Form by UV-Spectrophotometer and RP-HPLC

P. S, B. R, K. B.
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引用次数: 2

Abstract

Lifitegrast is an LFA-1 antagonist, tetrahydroisoquinoline derivative, formulated as sterile eyedrops. Lifitegrast ophthalmic solution 5.0% was the first medication approved by the US FDA for treatment of the signs and symptoms of DED. We developed and validated two novel, economic, specific, and sensitive UV spectrophotometric and RP-HPLC methods for estimation of lifitegrast in bulk and dosage form. The linearity was found in the concentration range of 05-30 μg/mL in UV method (R²=0.9995) and 2-12 μg/mL in HPLC method (R²=0.999) with good correlation coefficient. The LOD and LOQ were found to be 0.77 μg/mL and 2.33 μg/mL, respectively by UV method. RP-HPLC method was developed at SunFire C 18 column (250 × 4.6 mm i.d., 5μm) using methanol, acetonitrile, and water as a mobile phase in the ratio of 20:60:20 (v/v) (pH = 2.27 adjusted with orthophosphoric acid). The LOD and LOQ were found to be 0.50 μg/mL and 1.52 μg/mL respectively by HPLC method. These developed methods were validated according to ICH (Q2 (R1)) guidelines with the following validation parameters i.e., specificity, linearity, accuracy, precision, LOD, LOQ, robustness, and ruggedness. The results of the study proved the applicability of the method in routine analysis of lifitegrast.
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建立了用紫外分光光度计和反相高效液相色谱法测定原料药和制剂中立替格斯特的方法
Lifitegrast是一种LFA-1拮抗剂,四氢异喹啉衍生物,配制为无菌滴眼液。5.0%的Lifitegrast眼液是美国FDA批准的第一种用于治疗DED体征和症状的药物。我们开发并验证了两种新颖、经济、特异、灵敏的紫外分光光度法和反相高效液相色谱法来估计散装和剂型的立替格斯特。紫外法浓度范围为05 ~ 30 μg/mL (R²=0.9995),高效液相色谱法浓度范围为2 ~ 12 μg/mL (R²=0.999)呈良好的线性关系,相关系数较好。紫外法测定的定量限和定量限分别为0.77 μg/mL和2.33 μg/mL。采用反相高效液相色谱法,色谱柱为SunFire c18 (250 × 4.6 mm, 5μm),流动相为甲醇、乙腈和水,比为20:60:20 (v/v) (pH = 2.27,正磷酸调节)。高效液相色谱法测定其定量限为0.50 μg/mL,定量限为1.52 μg/mL。根据ICH (Q2 (R1))指南对这些开发的方法进行验证,验证参数包括特异性、线性度、准确度、精密度、LOD、LOQ、稳健性和耐用性。研究结果证明了该方法在日常寿命分析中的适用性。
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