In this study, we developed and validated a method to determine dipyridamole-related impurities in pharmaceutical dosage forms using the reversed-phase-HPLC technique. All impurities were separated on a YMC pack C8 (150 mm × 4.6 mm, 3.0 μm) analytical column using a suitable mobile phase. Mobile phase A was 10 mM concentration of phosphate buffer (pH adjusted to 4.7 by adding diluted orthophosphoric acid) and mobile phase B was buffer:acetonitrile:methanol (at the ratio of 30:40:30 v/v). The optimized chromatographic conditions used in the experiment were as follows: flow rate, 1.0 mL/min; injection volume, 10 μL and column temperature, 35°C. Chromatographic detection was performed at 295 nm. The stressed samples were analyzed for degradation under acidic, basic, peroxide, water hydrolysis, and physical degradation conditions. The proposed method was validated according to International Conference on Harmonization (ICH) guidelines, and found to be specific, linear, accurate and have a robust stability-indicating nature. The method showed excellent linearity from limit of quantification (LOQ) to 150% level of concentrations for all impurities. The correlation coefficient (r²) for all impurities was between 0.995 and 0.999. The recovery study was performed from LOQ to 150% level concentrations, with mean recovery values between 92.9% and 103.2%, respectively. The developed method can be used to determine dipyridamole and its relative impurities. The degradation and validated study results indicate its stability-indicating nature. Therefore, the method can be used in pharmaceutical research and development and quality control departments.

中文翻译：

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一种经过验证的稳定性指示反相 HPLC 方法，用于在药物剂型中存在降解产物及其工艺相关杂质的情况下检测双嘧达莫

在本研究中，我们开发并验证了一种使用反相 HPLC 技术测定药物剂型中双嘧达莫相关杂质的方法。所有杂质在 YMC pack C8 (150 mm × 4.6 mm, 3.0 μm) 分析柱上使用合适的流动相进行分离。流动相 A 为 10 mM 浓度的磷酸盐缓冲液（通过添加稀释的正磷酸将 pH 值调节至 4.7），流动相 B 为缓冲液:乙腈:甲醇（比例为 30:40:30 v/v）。实验中使用的优化色谱条件如下：流速，1.0 mL/min；进样量，10 μL，柱温，35°C。在 295 nm 处进行色谱检测。在酸性、碱性、过氧化物、水水解和物理降解条件下分析受压样品的降解情况。所提出的方法根据国际协调会议 (ICH) 指南进行了验证，发现其特异性、线性、准确并具有稳健的稳定性指示特性。该方法显示了从定量限 (LOQ) 到所有杂质浓度的 150% 水平的出色线性。相关系数（r² ) 对于所有杂质，在 0.995 和 0.999 之间。回收率研究从 LOQ 到 150% 水平浓度进行，平均回收率值分别在 92.9% 和 103.2% 之间。所开发的方法可用于测定双嘧达莫及其相关杂质。降解和验证的研究结果表明其稳定性指示性质。因此，该方法可用于药物研发和质量控制部门。