2018 Progesterone Method Validation Paper Raw Data

Raw data provided for research paper titled Development and Validation of a Stability Indicating HPLC Method for Quantification of Progesterone in Compounded Glycerinated Gelatin Troches. The objective of this study was to develop a validated stability indicating HPLC method that quantifies progesterone in compounded glycerinated gelatin troches. The mobile phase was composed of methanol and water (75:25 v/v) while the stationary phase was a Waters Nova-Pak C18 column (3.9 mm x 15 cm x 4.0 µm) with the column’s temperature set to 40 ⁰C. The injection volume was 20 µL while the gradient flow rate was maintained at 0.75 mL/min for a run time of 15 minutes. The detection wavelength for progesterone was set to 245 nm. In the forced degradation study, there was significant hydrolytic, oxidative, UV, and thermal degradation but insignificant photodegradation. However, no degradants co-eluted with progesterone. All method validation parameters met the respective acceptance criteria established by ICH guidelines. This developed and validated method is suitable for both routine potency/strength testing as well as stability testing of progesterone in compounded glycerinated gelatin troche dosage forms. The method was utilized to successfully quantify progesterone in multiple compounded preparations from two different compounding pharmacies.本数据集为下述研究论文提供原始数据：《复方甘油明胶锭剂中孕酮定量的稳定性指示型高效液相色谱法（High Performance Liquid Chromatography, HPLC）的开发与验证》。本研究旨在开发一种经验证的稳定性指示型高效液相色谱法，用于定量测定复方甘油明胶锭剂中的孕酮含量。该方法的流动相组成为甲醇与水（体积比75:25 v/v），固定相采用Waters Nova-Pak C18色谱柱（规格为3.9 mm × 15 cm × 4.0 µm），柱温设置为40 ℃。进样体积为20 µL，梯度流速维持在0.75 mL/min，运行时长为15分钟，孕酮的检测波长设定为245 nm。在强制降解试验中，样品发生显著的水解、氧化、紫外及热降解，但光降解程度可忽略，且未出现与孕酮共洗脱的降解产物。所有方法验证参数均符合人用药品注册技术要求国际协调会议（International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, ICH）制定的相应接受标准。本经开发并验证完成的方法，适用于复方甘油明胶锭剂剂型中孕酮的常规效价/强度检测以及稳定性考察。该方法已成功用于定量测定两家不同药品调剂药房制备的多批复方制剂中的孕酮含量。