Development and Validation of a Stability-Indicating RP-HPLC Method for the Estimation of Olanzapine in Pharmaceutical Dosage Forms

Abstract

A simple, rapid, accurate, precise, and stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Olanzapine in bulk drug and pharmaceutical dosage forms. Chromatographic separation was achieved on a Thermo C18 column (250 mm × 4.6 mm, 5 μm) using a mobile phase consisting of phosphate buffer (1.75 g KH₂PO₄ in 1000 mL water, pH 6.0 adjusted with orthophosphoric acid, containing 1 mL triethylamine) and acetonitrile in a ratio of 60:40 (v/v) at a flow rate of 1.0 mL/min. UV detection was carried out at 257 nm. Olanzapine showed a retention time of approximately 2.37 min. The method was linear over the concentration range of 5–25 μg/mL (r² = 0.998). Accuracy studies demonstrated recovery values of 99.75–100.10%. Precision studies yielded %RSD values below 2.0% for all parameters. Robustness evaluation confirmed stability under minor variations in chromatographic conditions. Forced degradation studies under acidic, alkaline, oxidative, and thermal stress conditions demonstrated the stability-indicating nature of the method. The developed method was validated as per International Conference on Harmonisation (ICH) Q2(R1) guidelines and is suitable for routine quality control and stability analysis of Olanzapine in pharmaceutical formulations.