Project goal

To create bio-analytical methods for fixed dose combinations that involve multiple analytes with diverse physico-chemical properties and entail challenging detection limits and large linear dynamic ranges.

Biggest challenges right now

• Sensitive methods to correctly define pharmacokinetic parameters
• Variable calibration curve range required for multiple strengths products
• Achieving high throughput by simultaneous analysis of multiple analytes with diverse physico-chemical properties from fixed dose combination products

Solution

• Sensitivity gains afforded by the SCIEX Triple Quad™ 6500 LC-MS/MS System for achieving challenging detection limits when sample volume is limited
• New IonDrive™ High Energy Detector technology of SCIEX Triple Quad™ 6500 system helps to have wide dynamic range method
• Fast Polarity switching in SCIEX Triple Quad™ 6500 system helps to analyze analyte of diverse polarity with lesser run time

Outcomes of research

• Developed several methods for CNS products and Irritable Bowel Syndrome (IBS) of pg/mL level for accurate depiction of pharmacokinetic parameters
• Successfully developed methods for many fix dose combination of anti-diabetic products
• Developed method for anti-malarial fix dose combination product for studies conducted on pediatric patients