A stability-indicating high-performance thin-layer chromatography (HPTLC) method was developed and validated for determination of arterolane maleate and piperaquine phosphate in combined dosage form. This study was carried out by using the mobile phase containing isopropyl alcohol:n-butanol:methanol:triethylamine (3:6:1:0.2 v/v). The method was validated as per the International Conference on Harmonization (ICH) guidelines. The correlation coefficient was found to be 0.9961 and 0.9914 in the concentration range of 150–900 and 750–4500 ng/band for arterolane maleate and piperaquine phosphate, respectively. The method had an accuracy of 98.25% for arterolane maleate and 97.15% for piperaquine phosphate. For stability study, arterolane maleate and piperaquine phosphate were subjected to acid, base, oxidation, heat, and photo-degradation studies. As the HPTLC method could effectively separate the drugs from their degradation products, it can be used for stability-indicating analysis.

中文翻译：

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稳定性指示HPTLC方法开发，用于测定复合剂型中的马来酸小ol烷酯和磷酸哌喹

建立了一种指示稳定性的高效薄层色谱法（HPTLC），并已通过该方法验证了联合剂型中马来酸小art烷酯和磷酸哌喹的含量。该研究是通过使用含有异丙醇的流动相进行的：正丁醇：甲醇：三乙胺（3：6：1：0.2  v / v）。该方法已根据国际协调会议（ICH）指南进行了验证。对于马来酸小ol烷酯和磷酸哌喹，在150–900和750–4500 ng / band的浓度范围内，相关系数分别为0.9961和0.9914。该方法对马来酸小ol烷的准确度为98.25％，对磷酸哌喹的准确度为97.15％。为了进行稳定性研究，对马来酸小ol烷酯和磷酸哌喹进行了酸，碱，氧化，热和光降解研究。由于HPTLC方法可以有效地将药物与其降解产物分离，因此可以将其用于稳定性指示分析。