A simple stability-indicating method was developed and validated for the determination of progesterone (a steroid drug) in the semi-solid dosage form. All the impurities were separated from the main compound with a simple stationary phase (Eclipse XDB, C8, 150 × 4.6 mm, 5 μm). The mobile phase A contained phosphate buffer and acetonitrile in the ratio of 90:10, v/v, and mobile phase B contained purified water and acetonitrile in the ratio of 10:90, v/v. The optimized chromatographic conditions were as follows: flow rate, 1.0 mL min⁻¹; UV detection, 241 nm; injection volume, 10 μL; and the column temperature, 30°C. The method was validated as per the current ICH Q2 guidelines. The recovery study and linearity ranges were established from 50 to 300% optimal concentrations. The method validation results were found between 98 and 102% for accuracy and r² = 0.999 for linearity. Forced degradation in hydrolytic, oxidative, thermolytic, and photostability conditions was performed, and the stability indicating nature of the method was proved. Based on the validation and forced degradation results, the current method was found to be specific, precise, accurate, linear, robust, and stability-indicating method. The developed method was cost effective and easy to handle for quality control analysis.

中文翻译：

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RP-HPLC/PDA检测器稳定性指示法测定半固体剂型（阴道凝胶）中的孕酮（类固醇药物）

开发并验证了一种简单的稳定性指示方法，用于测定半固体剂型中的黄体酮（一种类固醇药物）。使用简单的固定相（Eclipse XDB，C8，150 × 4.6 mm，5 μm）将所有杂质与主要化合物分离。流动相 A 含有比例为 90:10, v/v 的磷酸盐缓冲液和乙腈，流动相 B 含有比例为 10:90, v/v 的纯净水和乙腈。优化的色谱条件如下：流速，1.0 mL min ^-1; 紫外检测，241 nm；进样量，10 μL；柱温 30°C。该方法已根据当前的 ICH Q2 指南进行了验证。回收率研究和线性范围建立在 50% 到 300% 的最佳浓度之间。方法验证结果的准确度在 98% 到 102% 之间，线性度r ²  = 0.999。在水解、氧化、热解和光稳定性条件下进行了强制降解，证明了该方法的稳定性指示性质。基于验证和强制降解结果，发现当前方法是特异性、精确、准确、线性、稳健和稳定性指示的方法。所开发的方法具有成本效益且易于处理质量控制分析。