Development And Validation of a Simple Stability Indicating High Performance Liquid Chromatographic Method for The Determination of Miconazole Nitrate in Bulk and Cream Formulations

A simple, accurate, and stability-indicating high-performance liquid chromatographic (HPLC) method was developed and validated for the determination of miconazole nitrate in both bulk drug and cream formulations. Chromatographic separation was achieved using a C18 column with a mobile phase comprising acetonitrile and phosphate buffer in an optimized ratio. The method demonstrated excellent linearity, precision, accuracy, and robustness in accordance with ICH guidelines. Forced degradation studies were performed under various stress conditions, including acidic, basic, oxidative, thermal, and photolytic environments, to confirm the stability-indicating capability of the method. Miconazole nitrate was effectively separated from its degradation products, demonstrating the method’s specificity and reliability for routine quality control and stability testing. The proposed method is suitable for use in pharmaceutical laboratories for the regular analysis of miconazole nitrate in raw materials and topical dosage forms.