Hanimi Reddy Bapatu

About

I am a postgraduate in Chemistry with a Ph.D. in Analytical Chemistry and over 22 years of experience in the pharmaceutical industry. My career spans comprehensive expertise in analytical method development and validation for diverse dosage forms, including drug substances, solid orals, oral solutions, oral suspensions, parenteral formulations, suppositories, topical gels, and solutions. I am proficient in advanced analytical techniques such as HPLC, UPLC, GC, LC-MS/MS, GC-MS, ICP-MS, PSD, XRPD, and UV-VIS.
My core strengths include impurity characterization and qualification, genotoxic and nitrosamine impurity evaluation, Analytical Quality by Design (AQbD), drug–excipient interaction studies, and solid-state chemistry. Leveraging deep scientific knowledge and practical experience, I specialize in driving pharmaceutical products from concept to clinic—addressing formulation, analytical, and biopharmaceutical challenges while ensuring compliance with regulatory requirements for safety and efficacy. Additionally, I navigate complex patent landscapes to deliver innovative, value-added solutions that ultimately benefit patients.

Employment

• Azurity pharmaceuticals Director
  2023 - Present
• Slayback Pharma India LLP Director
  2016 - 2023
• Celltrion Manager
  2011 - 2016
• Dr. Reddy's Laboratories (India) Assistant Manager
  2004 - 2011

Education

• Jawaharlal Nehru Technological University, Hyderabad Ph.D.
  2009 - 2020
• Andhra University Master of Science ( M.Sc)
  2002 - 2004
• Acharya Nagarjuna University B.Sc.
  1999 - 2002

Projects & Funding

Projects & funding information is unavailable.

Publications (16)

• Engineered bimetallic electrode materials for sustainable and selective electroreduction of CO2 into value-added products
  Journal of Environmental Chemical Engineering 2026 DOI: 10.1016/j.jece.2026.124753
  +Save
• Development and Validation of RP‐HPLC Method for the Detection of N‐Nitroso Meglumine in Pharmaceutical Products
  Biomedical Chromatography 2025 DOI: 10.1002/bmc.70064
  +Save
• Identification and Structural Elucidation of a Potential Citric Acid and Caprolactam Adduct Impurity in Aminocaproic Acid Injection Using Preparative Chromatography, LC–MS, and NMR
  SEPARATION SCIENCE PLUS 2025 DOI: 10.1002/sscp.70031
  +Save
• Enhanced electrocatalytic CO2 reduction into formate: Unleashing the effect of engineered bimetallic oxides supported on activated carbon
  Applied Surface Science 2024 DOI: 10.1016/j.apsusc.2024.161468
  +Save
• Development of HPLC Method for Ixabepilone (Oncology Drug) in Bulk and Dosage Form: Quantification of Impurities and Forced Degradation Studies
  Journal of Chromatographic Science 2024 DOI: 10.1093/chromsci/bmad049
  +Save
• Development and Validation of a Method for Trace Level Zinc Quantification in Pharmaceutical Zinc Supplements Using a Carboxyl Functional Group Packed Column and Refractive Index Detector
  Journal of AOAC International 2024 DOI: 10.1093/jaoacint/qsad101
  +Save
• A QBD WITH THE FRACTIONAL FACTORIAL DESIGN WAS USED TO MATCH THE SIMILARITY BETWEEN RANOLAZINE EXTENDED-RELEASE TABLETS 500 MG AND 1000 MG
  International Journal of Applied Pharmaceutics 2023 DOI: 10.22159/ijap.2023v15i2.47241
  +Save
• Assessment of the Water Sorption Capacity of Rifaximin Using the Dynamic Vapor Sorption Technique for Optimization of the Choice of Excipients and the Manufacturing Environment of Rifaximin Tablets
  Journal of AOAC International 2023 DOI: 10.1093/JAOACINT/QSAD103
  +Save
• QbD Approach Method Development for Estimation of Dabigatran Etexilate along with Its Impurities and Identification of Degradants in Capsule Dosage Form
  American Journal of Analytical Chemistry 2016 DOI: 10.4236/ajac.2016.76047
  +Save
• Stability Indicating HPLC Method for Quantification of Solifenacin Succinate & Tamsulosin Hydrochloride along with Its Impurities in Tablet Dosage Form
  American Journal of Analytical Chemistry 2016 DOI: 10.4236/ajac.2016.711073
  +Save