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.

1. 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

1. 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

1. Instrument Handling

- Operate and maintain HPLC systems (e.g., Waters, Agilent, Shimadzu)

- Perform:

- Calibration

- System suitability testing (SST)



o Routine maintenance and troubleshooting

1. Documentation & Compliance • Maintain records as per Positive Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)

- Prepare:

- Analytical reports o Raw data records

- Logbooks

- Ensure data integrity (ALCOA principles)

1. Stability & Quality Control

- Perform stability sample testing

- Support QC release testing of finished products

Required Knowledge &

Skills Technical Knowledge

- Strong 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

📌 HPLC Analyst - Pharma Laboratory (Gurugram)
🏢 Vardan EnviroNet
📍 Gurugram