Detail-oriented B. Pharmacy graduate (GPAT qualified) seeking a Regulatory Affairs or Analytical role in a pharmaceutical organization. Experienced in HPTLC method development and validation per ICH Q2(R1), with training in USFDA/EU-GMP sterile injectable manufacturing and knowledge of eCTD submissions, GMP and ICH guidelines.
• Developed an HPTLC method for simultaneous estimation of both drugs using silica gel 60 F254 plates, mobile phase Ethyl acetate: Methanol: Formic acid (8:1.5:0.5 v/v/v), with densitometric detection at 254 nm (Camag TLC scanner) • Validated per ICH Q2(R1): linearity 500–10,000 ng/spot; recovery 96.56–104.65% w/w, consistent with label claim • Method proven precise, accurate, robust and reproducible