I am Dr. Rupali Akshay Wagh, currently working as an Assistant Professor in the Pharmaceutical Chemistry Department at SOPS, Sandip University, Nasik, India. I completed my Ph.D. in Pharmaceutical Analysis from NIPER Hyderabad in 2024, after earning my M. Pharm in Pharmaceutical Analysis from the same institute.
I have four years of R&D experience in leading pharmaceutical companies, including Mylan Labs, Megafine Pvt Ltd, and Glenmark Pvt Ltd. My research focuses on impurity profiling of drug substances and products using advanced hyphenated techniques such as LC-MS, NMR, and single-crystal XRD. I also work on method development and validation as per ICH guidelines, stability-indicating assay methods, microfluidics, and microcrystal generation. I have filed two patents for novel impurities and one for a microcrystal process with the association of NIPER and ZYDUS Lifesciences Limited.
I have published my research in high-impact international journals.( Journal of Pharmaceutical and B
EDUCATION
PhD IN Pharmaceutical analysis NIPER ,
RESEARCH, TEACHING, or OTHER INTERESTS
Pharmaceutical Science, Pharmacy, Analytical Chemistry, Drug Discovery
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Scopus Publications
Scopus Publications
Synthesis, Biological Evaluation, and Structure–Activity Relationships of Pyrrole Coumarin Conjugates Against Mycobacterium tuberculosis Preeti Rana, Manchella Sai Supriya, Mohammad Naiyaz Ahmad, Mohmmad Imran, Pradip Malik, et al. Chemistryselect, 2025 Considering the escalation of drug‐resistant tuberculosis, there is an emerging need to develop new anti‐tubercular agents with novel targets. In this context, a series of novel pyrrole coumarin conjugates were synthesized and evaluated against a mycobacterial pathogen panel consisting of Mycobacterium tuberculosis , M. abscessus , M. fortuitum , and M. chelonae . Most of the compounds exhibited selective anti‐tubercular activity against M. tuberculosis with MICs ranging from 2 to 64 µg/mL. The active compounds were nontoxic toward Vero cells, demonstrating a favorable selectivity index. The active compounds were also tested against drug‐resistant M. tuberculosis (DR‐MTB) strains and found to be active against all resistant strains, with MIC values ranging from 2 to 4 µg/mL. Molecular docking studies were performed to gain insight into their mechanism of action, elucidating the potential binding mode and interactions at the enzyme's active site. Further, molecular dynamics simulation studies were carried out to validate the results obtained from the molecular docking study.
Reverse-phase high-performance liquid chromatography methodology for film-forming mafenide spray: Compatibility, assay, and in-vitro release evaluation using Franz vertical diffusion cell apparatus Rupali Mahajan, Sai Teja Chandragiri, Vivek Borse, Gananadhamu Samanthula, Amit Asthana Separation Science Plus, 2024 This paper described a short and precise reverse‐phase high‐performance liquid chromatography (HPLC) method for quantifying mafenide in a film‐forming spray and preliminary in‐vitro release study. Following the International Council for Harmonization guidelines Q2 (R1), the method was validated. The chromatographic separation was achieved using a 10 mM potassium dihydrogen phosphate solution (mobile phase A) mixed with HPLC‐grade methanol (mobile phase B) in an 85:15 v/v ratio. Inert Sustain C8 (4.6 × 250 mm), 5 μm column was selected as the stationary phase. The flow rate was set as 0.8 mL/min, and detection was carried out at a wavelength of 222 nm. The developed HPLC method showed an accuracy between 98% and 102%. The primary diffusion study of film‐forming spray was performed using the Franz vertical diffusion cell apparatus. It was observed that an average of 26.94% of drug releases at 24 h. This indicates the drug has a slower release rate and shows local pharmacological action. The Weibull dissolution model was more fitting with regression square 0.9953. Furthermore, the drug excipient compatibility study revealed no interactions as the only drug peak was found in the chromatographic method, indicating that the chosen excipients were appropriate for a stable formulation.
Integrative analysis of tepotinib forced degradation: Combining in-silico and liquid chromatography-quadrupole time-of-flight-tandem mass spectrometry approaches for structural elucidation Rupali Mahajan, Aman Bishnani, Rekha Sapkal, Amol G. Dikundwar, Samanthula Gananadhamu, et al. Separation Science Plus, 2024 The present research aimed to comprehensively investigate the forced degradation of tepotinib through a combined in‐silico and experimental analysis. Tepotinib is a recently approved drug for metastatic non‐small cell lung cancer. A short and precise ultra‐high‐performance liquid chromatography (UHPLC) method utilizing a CSH C18 column (100 × 2.1 mm, 1.7 μm) was developed, using a mobile phase A as 0.1% formic acid and mobile phase B as HPLC‐grade acetonitrile. The flow rate was set at 0.2 mL/min, and detection was carried out at 260 nm. Forced degradation was carried out under acidic, basic, oxidative, and photolytic environments and also virtually with Zeneth software. Structural characterization of degradation products (DPs) was carried out using hyphenated techniques such as LC‐quadrupole time‐of‐flight‐tandem mass spectrometry in positive electrospray ionization mode. Further, toxicity was assessed with Derek and Sarah software. Analysis revealed the formation of five distinct forced DPs: DP‐1 ( m/z 511), DP‐2 ( m/z 527), DP‐3 ( m/z 525), DP‐4 ( m/z 512), and DP‐5 ( m/z 509) under experimental conditions and eight in Zeneth prediction. Furthermore, nephrotoxicity alerts were observed for DP‐3 and DP‐5, whereas DP‐3 also showed mutagenicity alerts. This integrated blend of in‐silico and real experimental analyses was found to be effective in quality control for routing monitoring of degradation products of tepotinib.
