反相高效液相色谱法同时测定糠酸莫米松和盐酸奥洛他定

IF 1.3 Q4 CHEMISTRY, ANALYTICAL SEPARATION SCIENCE PLUS Pub Date : 2024-05-10 DOI:10.1002/sscp.202300207
Bhoomi Patel, Ruchi Patel
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引用次数: 0

摘要

采用一种特异、精确、准确、快速、可靠且经济的高效液相色谱技术,开发并验证了糠酸莫美他松(MOM)和盐酸奥洛他定(OLO)的同时测定方法。分离过程中使用甲醇:水:乙腈(20:25:55,v/v/v)作为流动相。在反相 Phenomenex C18 色谱柱上进行低压梯度洗脱。在 238 纳米波长下,对分离的成分进行密度测定。流速固定为 1.0 mL/min,连续运行 10 分钟,OLO 和 MOM 的保留时间分别约为 3.2 分钟和 6.1 分钟。该方法的线性范围、精密度、重现性、特异性、准确度、检出限、定量限和稳健性均符合国际协调理事会 Q2(R1)指南的要求。在 2.5-15 µg/mL 和 33.25-199.5 µg/mL 的范围内,MOM 和 OLO 的回归系数(r2)分别为 0.9994 和 0.9997。MOM 和 OLO 的回收率分别为 99.49 ± 0.14 和 99.98 ± 0.22。该方法可成功用于MOM和OLO的常规定量分析。
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Simultaneous estimation of mometasone furoate and olopatadine hydrochloride by reversed‐phase high‐performance liquid chromatography
The simultaneous determination of Mometasone furoate (MOM) and Olopatadine hydrochloride (OLO) in a combined dose has been developed and validated using a specific, precise, accurate, fast, reliable, and economical high‐performance liquid chromatography technique. Methanol:water:acetonitrile (20:25:55, v/v/v) was used as the mobile phase during the separation. The procedure was performed using a low‐pressure gradient elution on the reversed‐phase Phenomenex C18 column. At 238 nm, separated components were densitometrically measured. The flow rate was fixed at 1.0 mL/min with a continuous run up to 10 min, while the retention time was located near about 3.2 and 6.1 min for OLO and MOM, respectively. The method was validated for Linearity and range, precision, reproducibility, specificity, accuracy, limit of detection, limit of quantification, and robustness as per the International Council for Harmonization Q2(R1) guideline. MOM and OLO regression coefficients (r2) were found to be 0.9994 and 0.9997, over the range of 2.5–15 and 33.25–199.5 µg/mL, respectively. MOM and OLO percentage recoveries were measured to be 99.49 ± 0.14 and 99.98 ± 0.22, respectively. The method can be successfully applied for routine analysis of the quantitative determination of MOM and OLO in a combined dose.
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来源期刊
SEPARATION SCIENCE PLUS
SEPARATION SCIENCE PLUS CHEMISTRY, ANALYTICAL-
CiteScore
1.90
自引率
9.10%
发文量
111
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