Key Responsibilities HPLC Analysis
Perform HPLC testing for:
Assay (active ingredient content) o Dissolution studies (mainly for tablets/capsules) o Related substances / impurities o Content uniformity
Prepare mobile phases, buffers, and standard/sample solutions.
Sample Handling
Analyze samples from:
Tablets, Capsules (hard/soft gelatin)
Syrups and oral liquids, Injection, Cream, Ointments and RM
Follow proper sample preparation techniques like:
Crushing, dilution, filtration, sonication
Method Execution & Validation
Execute analytical methods as per:
Pharmacopoeia (IP, USP, BP) o In-house methods
Participate in:
Method validation o Method transfer o Verification activities
Instrument Handling
Operate and maintain HPLC systems (e.g., Waters, Agilent, Shimadzu)
Perform:
Calibration
System suitability testing (SST)
o Routine maintenance and troubleshooting
Documentation & Compliance • Maintain records as per Valuable Manufacturing Practices (GMP) and Positive Laboratory Practices (GLP)
Prepare:
Analytical reports o Raw data records
Logbooks
Ensure data integrity (ALCOA principles)
Stability & Quality Control
Perform stability sample testing
Support QC release testing of finished products
Required Knowledge & Skills Technical Knowledge
Robust understanding of:
HPLC principles (chromatography, detectors, columns) o Pharmaceutical dosage forms (tablets, capsules, syrups) o Dissolution apparatus (USP I/II)
Familiarity with:
Pharmacopoeias (IP, USP, BP)
OOS (Out of Specification) handling