International Journal of Drug Delivery Technology
Volume 15, Issue 3

Stability-Indicating RP-HPLC Method Development and Validation for the Estimation of Inavolisib in Bulk and Pharmaceutical Dosage Form

Selvaraja Elumalai*, Meenakshi Sharma 

Department of Chemistry,School of Basic and Applied Sciences, Raffles University, Neemrana, Alwar, Rajasthan-301705, India 

Received: 29th May, 2025; Revised: 26th Jun, 2025; Accepted: 18th Jul, 2025; Available Online: 25th Sep, 2025 

ABSTRACT

A robust and stability-indicating RP-HPLC method was developed and validated for the estimation of Inavolisib in bulk and its pharmaceutical formulations. Separation was achieved on a Symmetry Shield RP-18 column (150 × 4.6 mm, 3.5 µm) using an isocratic mobile phase comprising acetonitrile and 0.1% triethylamine (pH adjusted to 2.5 with orthophosphoric acid) in a 1:1 ratio. The method utilized a 1.0 mL/min flow rate with detection at 245 nm. Validation, as per ICH Q2(R1) guidelines, demonstrated excellent specificity, linearity (R² = 0.99967), precision (%RSD < 2%), and accuracy (recovery 99.8–99.9%). The method also proved to be robust and sensitive, with LOD and LOQ values of 0.54 µg/mL and 1.80 µg/mL, respectively. The assay of the marketed product Itovebi confirmed 100.1% of the labeled content. Forced degradation studies under various stress conditions confirmed the method’s capability to separate the drug from its degradation products, supporting its application as a reliable and stability-indicating analytical method for routine quality control of Inavolisib.

Keywords: Inavolisib, RP-HPLC, Method validation, Stability-indicating, Forced degradation

How to cite this article: Selvaraja Elumalai, Meenakshi Sharma. Stability-Indicating RP-HPLC Method Development and Validation for the Estimation of Inavolisib in Bulk and Pharmaceutical Dosage Form. International Journal of Drug Delivery Technology. 2025;15(3):1114-18. doi: 10.25258/ijddt.15.3.29

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