About the Dept. of Pharmaceutical Analysis

Quality Policy

“Committed to excel in precise analytical technology through adopting advanced techniques and shall endeavour to ensure the concrete outcome for societal needed research in collaboration with stakeholders of health professionals”

Preamble

The department of pharmaceutical analysis at NIPER-Hajipur is started in the academic year (ACY) 2021-22 with M.S (Pharm.), integrated PhD and PhD degree in pharmaceutical analysis. The department has also been designated to support Central instrumentation facility (CIF) for inter-departmental /collaborative research initiatives. The pharmaceutical analysis specialization focuses the science and skills in the new analytical method development and validation of procedure using different analytical principles like chromatography, spectroscopy, thermal methods etc., trouble shooting of analytical procedure, quality control of pharmaceuticals /biopharmaceuticals/ nutraceuticals/ phytopharmaceuticals. Our department is striving for collaborative research in proteomics area for drug target validation, biomarkers discovery, chemo-proteomics and post translational modification.  In addition, the department is also participating in establishing of “Centre of excellence in biologics” for analytical characterization, stability and release. The department is pioneer in establishing analytical quality by design (AQbD) at par with the requirement of ICHQ14, stability studies, NCE characterization, genotoxicity profiling, preclinical pharmacokinetics etc. The department entitled to implement GMP/GLP practices.

Infra-Structure

The laboratory is established with adequate space including, Change room, Wet analysis laboratory, Sample preparation area, Central facility – 1 (LC-MS(Orbitrap)/ Proteomics lab), Central facility-2 (LC-MS/MS (QQQ), GC-MS/MS, UV/Visible-NIR-DRS, FT-IR), Central facility-3 (ICP-MS), HPLC, stability chamber, QbD tool, Flash-LC, and other wet laboratory equipment/devices, Hazard Chemical zone (Fume Hood area), Chemicals storage area. The Laboratory implemented the minimum GLP requirements, SOPs, fire safety requirement, Log-books, exit-entry record, sample/standards storage record, calibration/maintenance record, PPE, Hazard disposal etc.

Degree offered

• M.S (Pharm.) degree (2 Years)
• PhD degree (Max. 5 Years)
• Integrated PhD (only for NIPER-JEE 2023 admitted – Max. 5 Years)

Research Focus of the department

• LC-HRMS based proteomics profiling of microbial, animal tissue and human and functional proteomics like phosphoproteomics, Glycoproteomics, Ubiquitomics .
• Analytical characterization of biological like peptide mapping, sequence analysis, higher order structure, protein folding etc.
• NCE synthesis & biological evaluation, LC-MS/MS based screening of bioactive ligands.
• Serum metabolomics Data development and identification secondary metabolite of bioactive natural products.
• Nitrosamine control in pharmaceutical products and genotoxic degradation product profiling.
• Industry relevant analytical method development using LC-HRMS, GC-MS/MS, HPLC/Prep. HPLC using AQbD/QSRR/ICHQ14.
• LC-ICP-MS based speciation analysis of toxic metals

Ongoing Research Grants

Research grants:  04  (280 Lakhs ; ICMR (03) + 01 (DST-SERB)

Publication: 65

Patent: 02 (01 filed+ 01 granted)

Grants details

1. ICMR Extramural Grant (PI: Dr P Ramalingam) “In vitro and in vivo evaluation of liposome encapsulated mycobacteriophages D29 and TM4 as therapeutic candidates against Mycobacterium tuberculosis (IIRPSG-2024-01-01066) 2025-2028, Grant value: 1.3 crore (Co-PI: Dr Abhishek Sahu and Dr Murali Kumarasamy)
2. ICMR (First in the World Challenge) Grant (Institute PI: Dr P Ramalingam): First in World challenge. A Nasal Spray Formula for Pulmonary Delivery to Control Multidrug-Resistant Tuberculosis MDR-TB (FIW-2024-01-00000252), 2025-2029 Grant value: 79.75 Lakhs (Co-PI: Dr Rahul G)
3. ICMR Extramural Grant (PI: Dr P Ramalingam): Potency optimization of 4-oxoazetidine scaffolds as dual specific polyphosphate kinase inhibitors for multi-drug-resistant tuberculosis (EM/Dev/SG/210/5331/2023), 2024-2027), Grant value: 47.5 Lakhs (Co-PI: Dr Anupam Jana & Dr Murali Kumarasamy)
4. DST-SERB (Start-up) Grant (PI: Dr Anupam Jana): Enantioselective Total Synthesis and Evaluation of Anti-Cancer Activity of Panduratins A-F and their Analogues, 2023-25, Grant value: 22.8 Lakhs.

Faculty and Research Team

1. Dr P Ramalingam, Associate Professor and Head (i/c)

2. Dr. Suhani Sinha, Associate Professor

3. Dr. Amita Rai, Assistant Professor

4. Dr. Narmada Vallakeerthi, Assistant Professor