The main aim is to develop a simple, rugged, and sensitive method for determining the Montelukast Sodium-related impurities in a tablet dosage form using reverse-phase high-performance liquid chromatography (RP-HPLC) method. Chromatographic separation on the Agilent Eclipse XDB C18 (octadecylsilane) column of the dimension (100 mm × 4.6 mm, 5 µm) was carried out in the gradient mode with triethylamine and acetonitrile in various combinations and adjusted to a pH of 6.60 using phosphoric acid. The mobile phase was pumped at a flow rate of 1.0 mL min⁻¹ and the analyte was monitored with a UV detector at a wavelength of 220 nm. The method was developed and validated under the stress conditions such as acidic, basic, peroxide, thermal, photolytic, and humidity degradation, respectively. Under the above conditions, oxidative degradation was performed which served as the system suitability solution providing a resolution of 2.5 between the Impurity 3 (retention time = 13.8 min) and Montelukast Sodium (retention time = 24.2 min). The method was validated with respect to specificity, linearity, precision, accuracy, limit of detection, and limit of quantification provided by the ICH guidelines. Results of linear regression analysis of the calibration plot revealed a good linear relationship between response and concentration with a correlation coefficient value of r² = 0.9999. The accuracy of known impurities was obtained in the range of 94–108%. From the analysis, their LOD and LOQ values for impurities were measured and found to be 0.007 and 0.025 μg g⁻¹, respectively. Chromatographic interference was not found during the degradation and excipients were detected from the tablet. The proposed method was successfully used to estimate the Montelukast Sodium-related impurities in a tablet dosage form.

主要目的是开发一种使用反相高效液相色谱 (RP-HPLC) 方法测定片剂剂型中孟鲁司特钠相关杂质的简单、耐用且灵敏的方法。在 Agilent Eclipse XDB C18（十八烷基硅烷）色谱柱（100 mm × 4.6 mm，5 µm）上以梯度模式进行色谱分离，使用三乙胺和乙腈的各种组合，并使用磷酸将 pH 值调节至 6.60。流动相以 1.0 mL min ^-1的流速泵入用紫外检测器在 220 nm 波长下监测分析物。该方法分别在酸性、碱性、过氧化物、热、光解和湿度降解等应力条件下开发和验证。在上述条件下，进行氧化降解，作为系统适用性解决方案，在杂质 3（保留时间 = 13.8 分钟）和孟鲁司特钠（保留时间 = 24.2 分钟）之间提供 2.5 的分辨率。该方法在 ICH 指南提供的特异性、线性、精密度、准确度、检测限和定量限方面得到验证。校准图的线性回归分析结果显示响应与浓度之间存在良好的线性关系，相关系数值为r²  = 0.9999。已知杂质的准确度在 94-108% 范围内。根据分析，测量了它们的杂质 LOD 和 LOQ 值，发现分别为 0.007 和 0.025 μg g ^-1。降解过程中未发现色谱干扰，从片剂中检测到赋形剂。所提出的方法已成功用于估计片剂剂型中与孟鲁司特钠相关的杂质。