1 Department of Pharmaceutical Quality Assurance, Kai Yashodabai Dagadu Saraf Charitable Trusts College of Pharmacy Sakegaon.
2 Department of Regulatory Affair, Base medico pvt ltd.
GSC Biological and Pharmaceutical Sciences, 2026, 36(01), 040-049
Article DOI: 10.30574/gscbps.2026.36.1.0244
Received on 19 May 2026; revised on 29 June 2026; accepted on 01 July 2026
A simple, precise, and accurate stability-indicating RP-HPLC method was developed and validated for Sirolimus determination. Chromatographic separation was performed on a Chromosil C18 column using methanol:acetonitrile (80:20 v/v) as the mobile phase at a flow rate of 1.0 mL/min, with UV detection at 272 nm. The method was validated following ICH guidelines. Forced degradation studies confirmed the method’s stability-indicating capability. This method is suitable for routine quality control and stability studies of Sirolimus.
Sirolimus, RP-HPLC; Validation; Stability-indicating method; Forced degradation; ICH
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Tejal C Chaudhari, Rajesh G Jadhao and Dhanraj V Konde. Stability indicating RP-HPLC method development and validation for sirolimus. GSC Biological and Pharmaceutical Sciences, 2026, 36(01), 040-049. Article DOI: https://doi.org/10.30574/gscbps.2026.36.1.0244.