ICH M10 Method Validation: Quantitating Ketorolac in Vitreous and Aqueous Humor Using Plasma as a Surrogate Matrix

Ocular clinical trials face a recurring bioanalytical constraint: human vitreous and aqueous humor are scarce and difficult to procure in volumes sufficient for full method validation. In this poster, Emery Pharma scientists, in collaboration with Rayner Surgical, validate human plasma as a surrogate matrix for the LC-MS/MS quantitation of ketorolac in vitreous and aqueous humor. Validation was performed end-to-end against ICH M10 guidelines, removing the need to procure rare ocular matrix prior to clinical trial initiation.

Complete the form below to download the full PDF.

"*" indicates required fields

This field is for validation purposes and should be left unchanged.
This site is protected by reCAPTCHA.
Poster 1 Preview

What You Will Learn

The rationale for selecting human plasma as a surrogate matrix for vitreous and aqueous humor

The protein precipitation and LC-MS/MS workflow used to extract ketorolac and its deuterated internal standard

Full ICH M10 validation results: selectivity, carryover, linearity (R² > 0.999), accuracy, precision, recovery, and dilution integrity

Stability data across freeze/thaw, bench-top, long-term (−80 °C), and autosampler conditions

How a validated surrogate matrix approach can de-risk method readiness ahead of an ocular clinical trial

Download Poster