Prof. G.V.Subba Reddyh as done extensive research work for the applications of Electrochemical and Chromatographic techniques in the quantitative estimation of drugs & Pharmaceuticals, impurities and Geno toxic species, pesticide residues, heavy & trace metal analysis in environmental samples. The nominee also involved in the synthesis of new facile biologically active compounds and biological screening of various APIs including docking studies. He has published more than 95 research articles and guided 18 Ph.D degree under his supervisor
An update on latest regulatory guidelines and analytical methodologies for N-nitrosamine impurities in pharmaceutical products - 2024 Krishna Moorthy Manchuri, Akhilesh Kumar Kuril, Mahammad Ali Shaik, Venkata Subba Reddy Gopireddy, Naziya Sultana Medical Gas Research, 2025 Controlling or eliminating N-nitrosamine impurities in pharmaceutical products has become a significant challenge for both drug manufacturers and regulatory authorities. This difficulty is particularly pronounced in light of the recent increase in nitrosamine drug substance-related impurities, which have raised concerns about the safety and efficacy of various medications. Additionally, the pharmaceutical industry faces the challenge of developing analytical methods that are not only sensitive and selective but also precise and accurate. These methods are crucial for the reliable quantification of low levels of N-nitrosamine impurities, ensuring compliance with stringent current regulatory guidelines. The intricate nature of detecting these impurities at such low levels necessitates the use of cutting-edge analytical techniques, such as liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry. In light of these challenges, this review article explores the latest regulatory guidelines and analytical methodologies concerning N-nitrosamine impurities in various pharmaceutical products for 2024. Findings from this review article help provide valuable insights for researchers and industry professionals to enhance the safety and quality of pharmaceutical products.
Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices Krishna Moorthy Manchuri, Mahammad Ali Shaik, Venkata Subba Reddy Gopireddy, Naziya Sultana, Sreenivasarao Gogineni Chemical Research in Toxicology, 2024 Since 2018, N-nitrosamine impurities have become a widespread concern in the global regulatory landscape of pharmaceutical products. This concern arises due to their potential for contamination, toxicity, carcinogenicity, and mutagenicity and their presence in many active pharmaceutical ingredients, drug products, and other matrices. N-Nitrosamine impurities in humans can lead to severe chemical toxicity effects. These include carcinogenic effects, metabolic disruptions, reproductive harm, liver diseases, obesity, DNA damage, cell death, chromosomal alterations, birth defects, and pregnancy loss. They are particularly known to cause cancer (tumors) in various organs and tissues such as the liver, lungs, nasal cavity, esophagus, pancreas, stomach, urinary bladder, colon, kidneys, and central nervous system. Additionally, N-nitrosamine impurities may contribute to the development of Alzheimer's and Parkinson's diseases and type-2 diabetes. Therefore, it is very important to control or avoid them by enhancing effective analytical methodologies using cutting-edge analytical techniques such as LC-MS, GC-MS, CE-MS, SFC, etc. Moreover, these analytical methods need to be sensitive and selective with suitable precision and accuracy, so that the actual amounts of N-nitrosamine impurities can be detected and quantified appropriately in drugs. Regulatory agencies such as the US FDA, EMA, ICH, WHO, etc. need to focus more on the hazards of N-nitrosamine impurities by providing guidance and regular updates to drug manufacturers and applicants. Similarly, drug manufacturers should be more vigilant to avoid nitrosating agents and secondary amines during the manufacturing processes. Numerous review articles have been published recently by various researchers, focusing on N-nitrosamine impurities found in previously notified products, including sartans, metformin, and ranitidine. These impurities have also been detected in a wide range of other products. Consequently, this review aims to concentrate on products recently reported to contain N-nitrosamine impurities. These products include rifampicin, champix, famotidine, nizatidine, atorvastatin, bumetanide, itraconazole, diovan, enalapril, propranolol, lisinopril, duloxetine, rivaroxaban, pioglitazones, glifizones, cilostazol, and sunitinib.
Development and validation of LC–QTOF–MS/MS method for the identification and determination of low levels of a genotoxic impurity, 4,6-dichloro-5-nitro-2-(propylthio)pyrimidine in ticagrelor API Manchuri Krishna Moorthy, Shaik Mahammad Ali, Gopireddy Venkata Subba Reddy Biomedical Chromatography, 2022 The foremost objective of the present study is to develop and validate a new LC-QTOF-MS/MS method for identification and quantitative determination of 4,6-dichloro-5-nitro-2-(propylthio) pyrimidine (DPP) genotoxic impurity through derivatization process in ticagrelor active pharmaceutical ingredient (API). Due to low response of DPP at specification level, the DPP is converted to 4,6-dibenzylamino-5-nitro-2-(propylthio) pyrimidine (DPP derivative) by addition of benzyl amine, then analyzed using mass spectrometry with a time-of-flight analyzer and accomplished good separation under the experimental conditions described. The effective separation of DPP derivative was achieved using ACQUITY UPLC BEH C18 reverse phase column (100 mm x 4.6 mm x 1.7 μm) with an isocratic program wherein mobile phase-A used as 0.1% formic acid in milli Q water and mobile phase-B used as acetonitrile in the ration of 20:80 v/v. Flow rate maintained 0.4 mL/min, injection volume 2 μL, auto sampler temperature 5°C, column oven temperature ambient and run time 6.0 minutes. Diluent used as 0.2% benzyl amine in water and acetonitrile in the ratio of 30:70 v/v. Retention time of DPP derivative was found at 2.87 minutes. Limit of detection (LOD) and limit of quantification (LOQ) were found at 0.03 ppm and 0.08 ppm, respectively. The DPP derivative was linear from 1.68 ppm to 12.78 ppm with R2 of 0.9958. Thus, the developed method is valid for identification and quantitative determination of 4,6-dibenzylamino-5-nitro-2-(propylthio) pyrimidine (DPP derivative) in ticagrelor API.
Synthesis Docking Studies and Antitubercular Activity of Ofloxacin Scaffold using Blanc Reaction C. Ramakrishna, G.V. Subbareddy Asian Journal of Chemistry, 2022 Synthesis, molecular docking and characterization of ofloxacin derivatives and in vitro evaluation for their antitubercular action were carried out. Synthesis ofloxacin derivatives viz. O+TRI, O+MEL, O+NAP, O+SUL, O+METF, O+IBU, O+ASP, O+DNP, O+SSA, O+PH, O+MC (where TRI = trimethoprim, MEL = meloxicam, NAP = naproxen, SUL = sulfamethoxazole, METF = metformin, IBU = ibuprofen, ASP = aspirin, DNP = 2,4-dinitrophenyl hydrazine, SSA = 5-sulpho salicylic acid, PH = phenyl hydrazine, MC = 7-hydroxy-4-methyl coumarin) were carried using Blanc reaction and purified by using of ethanol by recrystallization. The reaction products consist of methylene group linkage between two moieties and the molecules were characterized by analytical methods TLC, solubility, melting point, spectroscopic methods (FT-IR, mass and 1H NMR, 13C NMR). In silico methods were adopted for synthetic derivatives by Autodock vina software. Determined physico-chemical parameters (in silico studies) and docking studies have been performed using protein (5BS8) with designed ligands, binding energy scores were noted for different derivatives. Derivatives O+TRI, O+NAP shown good activity at 0.8 μg/mL. In docking studies, all the compounds shown promising results when compared to standard drugs.
In situ generation of antibacterial silver nanocomposite cotton fabrics by bio route Prasad Akepogu, Umamahesh Mallavarapu, Venkata Subbareddy Gopireddy, Jaswanth Seetha, Arundathi Mesa, Varaprasad Duddela, Varada Rajulu Anumakonda Inorganic and Nano Metal Chemistry, 2021 Antibacterial silver nanocomposite cotton fabrics were generated by in situ method using Senna auriculata (SA) leaf broth as reductant. Silver nanoparticles (AgNPs) synthesized on cotton fabrics (nanocomposite cellulose fabrics [NCCFs]) were analyzed by different spectral characteristics like FTIR, SEM correlated with EDX and XRD. The SEM analysis revealed that the generated AgNPs on NCCFs were spherical in shape with a mean size of 100 nm. The XRD studies showed that the biosynthesized NCCFs are exhibiting FCC crystalline lattice structure. The FTIR spectra indicated that the hydroxyl functional group in leaf extract is responsible for bioreduction of silver ions into metallic silver. The TG-DTG and DSC analysis showed higher thermal stability and the deterioration in stages. The biogenerated AgNPs in NCCFs exhibited good antibacterial activity against Gram-positive and Gram-negative pathogenic bacteria. The NCCFs also exhibited good mechanical strength. The NCCFs with bio generated AgNPs can be considered for medical and packing applications.
Seasonal variation of trace and heavy metals in vegetable plants around tummalapalle uranium mining site S. Kulavardhana Reddy, C. Sivanandha Reddy, Gopireddy Venkata Subba Reddy Rasayan Journal of Chemistry, 2020 This study has investigated the source and magnitude of trace and heavy metal contamination of various kinds of vegetable plants in the close vicinity of the uranium mining area during the pre-monsoon and post-monsoon seasons. All vegetable samples were collected from the selective agricultural fields and analyzed by Inductive Coupled Plasma Optical Emission Spectroscopy (ICP-OES). The mean concentrations of trace and heavy metals in vegetable plants were found to be in the range of 0.01-0.24 49.27-56.41, 0.028-4.65 , 0.72-6.29 , 35.05-73.47 , 12.44-19.61 , 0.014-0.068 , 0.029-0.18 , 2.081-7.52 , 0.022-0.28 , 0.01-3.01, 0-0.008 B, Ca, Cu, Fe, K, Mg, Mn, Mo, P, Zn, Pb, and Se in pre-monsoon season. During the post-monsoon season 0.14-1.09 ,45.64-57, 0.45-3.54, 37.33-62.44, 67.73-89.3 , 12.45-23.32, 0.65-4.87, 0.53-2.96, 21.65-28.3, 0.35-1.12, 0.028-0.61, 0.013-0.097 B, Ca, Cu, Fe, K, Mg, Mn, Mo, P, Zn, Pb and Se found in plants. The trace and heavy metals were observed in the field and compared with the literature values and some guidelines. The trace and heavy elemental data were analyzed through statistical tools to examine the interrelationship among the investigated trace and heavy elements and possible source identification of the trace metal contamination in vegetable plants.
A validated simultaneous estimation of budesonide and nifedipine in pharmaceutical formulation by RP-HPLC method International Journal of Research in Pharmaceutical Sciences, 2017
Synthesis, biological evaluation of novel quinoline and its derivatives of Schiff’s base compounds from catalytic free green solvent International Journal of Pharmaceutical Research, 2017
Determination of cefdinir and cefditoren by zero order and first order derivative spectrophotometry Der Pharmacia Lettre, 2015
Formulation design and in vitro evaluation of Zolmitriptan immediate release tablets using Primojel and AC-Di-Sol Journal of Pharmaceutical Sciences and Research, 2015
Synthesis, characterization, biological evaluation and docking studies of organo phosphorous pyrazole5-one derivatives of 1,2,4-triazoles and sulfones derivatives of sortase A staphylococcus inhibitors Der Pharma Chemica, 2015
Formulation design and in vitro evaluation of bilayer sustained release matrix tablets of doxofylline International Journal of Pharmacy and Pharmaceutical Sciences, 2015
Synthesis, characterization, biological evaluation and docking studies of organo phosphorous pyrazole5-one derivatives of Isatine Mannich bases derivatives of sortase A staphylococcus inhibitors Der Pharma Chemica, 2015
Formulation design and study the effect of polyplasdone-XL and AC-Di-Sol on release profile of doxofylline immediate release tablets International Journal of Pharmaceutical Sciences Review and Research, 2015
Determination of residues of deltamethrin in water and liver tissue of Zebrafish (Danio rerio) by HPLC Der Pharma Chemica, 2015
Enzyme activities of Nile tilapia (Oreochromis niloticus) during lethal and sublethal exposure to cypermethrin Der Pharma Chemica, 2015
Synthesis of new 4-aryl-3, 4-dihydropyrimidin-2(1H)-ones/ thiones/ imines and their antimicrobial evaluation Journal of Chemical and Pharmaceutical Research, 2014
Process optimization, formulation and evaluation of hydrogel {Guar gum-g-poly (acrylamide)} based doxofylline microbeads Asian Journal of Pharmaceutical and Clinical Research, 2014
Development and validation of UV-spectrophotometric methods for estimation of ceftriaxone in bulk and tablet dosage form International Journal of Chemtech Research, 2013
Development, validation and application of UV spectrophotometric method for the determination of roxithromycin in bulk and pharmaceutical dosage form Journal of Chemical and Pharmaceutical Research, 2012
Validated method for vinblastin by spectrophotometry in bulk drug and pharmaceutical formulations Journal of Chemical and Pharmaceutical Research, 2012
Study and improvement of spectrophotometric and HPLC methods for the determination of nitazoxanide in pharmaceutical preparations Journal of Chemical and Pharmaceutical Research, 2012
A validated UV spectrophotometric determination of an antiviral drug zanamvir from tablet formulations Journal of Chemical and Pharmaceutical Research, 2012
Synthesis, spectral characterization and biological activity of 1,3,2-dioxaphosphinane derivatives International Journal of Pharma and Bio Sciences, 2012
Polarographic reduction behaviour of some potential antibiotic cephalosporins International Journal of Pharmacy and Pharmaceutical Sciences, 2010
Polarographic study and electroanalytical determination of nitrendipine Indian Journal of Environmental Protection, 2001
Electroanalysis of nitrofuran drugs Indian Drugs, 1999
Electrochemical reduction behaviour of 1-(4-chlorophenyl)-3-(4- nitrophenyl)-2,3-epoxy propan-1-one Bulletin of Electrochemistry, 1998
RECENT SCHOLAR PUBLICATIONS
Spatial Distribution of Uranium Water Quality on Seasonal Basis around Proposed Nuclear Power Plant D Ramarao¹, M Yugandhar, GVS Reddy, SK Sahoo, AV Kumar, ... Proceedings of the International Conference on Resilient Innovations for … , 2026 2026
An update on latest regulatory guidelines and analytical methodologies for N-nitrosamine impurities in pharmaceutical products–2024 KM Manchuri, AK Kuril, MA Shaik, VSR Gopireddy, N Sultana Medical Gas Research 15 (4), 535-543 , 2025 2025 Citations: 9
Optimal Frequency Control of Multi Area Power System Under Restructured Environment SA Kumar, VA Lakshmi, GVS Reddy, YR Mohan, AVK Reddy International Journal of Electrical and Electronics Research 13 (3), 557-562 , 2025 2025
AGC of Multi Area Solar-Thermal System Under Open Market Scenario SA Kumar, KS Gowri, SG Haritha, BVA Kumar, GVS Reddy International Conference on Advanced Materials, Manufacturing and … , 2025 2025 Citations: 2
Analytical methodologies to detect n-nitrosamine impurities in active pharmaceutical ingredients, drug products and other matrices KM Manchuri, MA Shaik, VSR Gopireddy, N Sultana, S Gogineni Chemical Research in Toxicology 37 (9), 1456-1483 , 2024 2024 Citations: 49
Bio-extracts of Citrus limon leaves in the beneficiation of coal used in thermal power generation GR Ulavapalli, K Ravindhranath, GVS Reddy, SR Duvvuri Biomass Conversion and Biorefinery 14 (13), 13971-13985 , 2024 2024 Citations: 1
Coal quality enhancement by using bio extracts of carissa carandas fruits in combination with Hydro Fluoric acid VMKGVSR 1. Gangadhara Reddy Ulavapalli, Rambabu Koyilapu, T. Gouri Chran International Journal of Coal Preparation and Utilization 44 (1), https … , 2024 2024 Citations: 3
Beneficiation of Coal with Biochemical Method and Effect of Treated Coal on Boiler Efficiency in Power Generatation. GR ULAVAPALLI, R KOYILAPU, GVS REDDY, TG CHRAN, VM KRISHNA, ... Oriental Journal of Chemistry 39 (5) , 2023 2023 Citations: 1
Dissipation Kinetics of Imidacloprid and Thiamethoxam in a Sweet Lime Orchard Soil Near Pulivendula using Ultra-Hplc Coupled with a Photodiode Array Detector (PDA). R Ramadevi, C Ramachandraiah, GVS Reddy Current Agriculture Research Journal 11 (1) , 2023 2023
Beneficiation of Coal with Biochemical Method and Effect of Treated Coal on Boiler Efficiency in Power Generation 2. Gangadhara Reddy Ulavapalli, Rambabu Koyilapu, G. V. Subba Reddy , T ... Oriental Journal of Chemistry 39 (5), 1133-1144 , 2023 2023
Development of a multi-residue method for 11 multiclass pesticides in a sweet lime orchard soil near Pulivendula using GC–MS/MS with Quechers extraction CRGVSR R.Ramadevi Eur. Chem. Bull 12 (3), 790-804 , 2023 2023
Development of A Multi Residue Method for the Quantification of 45 Pesticides using GC-MS/MS and Study of Peeling Effect on Pesticide Residues in Citrus Fruits GVSR R. Ramadevi, C. Ramachandraiah Orient. J. Chem 39 (5), 1145-1155 , 2023 2023 Citations: 4
A novel UHPLC–MS/MS method development and validation for identification and quantification of genotoxic impurity bis (2-chloroethyl) amine in aripiprazole drug substance KM Manchuri, MA Shaik, VSR Gopireddy Chromatographia 85 (2), 137-146 , 2022 2022 Citations: 10
A new LC-QTOF-MS/MS method development and validation for identification and ultra-trace level quantification of genotoxic impurity 1,3-diacetoxy-2-(acetoxymethoxy) propane in … GVSR Manchuri Krishna Moorthy, Mahammad Ali Shaik Separation Science Plus 5 (3-4), 84-92 , 2022 2022
Synthesis Docking Studies and Antitubercular Activity of Ofloxacin Scaffold using Blanc Reaction GVS C. Ramakrishna Asian J. of Chemistry 34 (3), 644-650 , 2022 2022
Development and validation of LC–QTOF–MS/MS method for the identification and determination of low levels of a genotoxic impurity, 4,6-dichloro-5-nitro-2-(propylthio)pyrimidine … GVSR Manchuri Krishna Moorthy, Mahammad Ali Shaik Biomedical Chromatography 36 (4), e5336 , 2022 2022 Citations: 13
Bio Extracts of Citrous Limon Leaves in the beneficiation of Coal used in Thermal Power generation GVSR U. Gangadhar Reddy J of Biomass Conversion and Biorefinery 1 (2), 1-15 , 2022 2022
A Review on Contamination of Soil and Water by Neonicotinoid Pesticides and Trends it’s in Soil and Water Samples with Chromatographic Analytical Techniques CRGVSR R. Ramadevi Orient. J. Chem 38 (2), 259-267 , 2022 2022 Citations: 11
In situ generation of antibacterial silver nanocomposite cotton fabrics by bio route P Akepogu, U Mallavarapu, VS Gopireddy, J Seetha, A Mesa, V Duddela, ... Inorganic and Nano-Metal Chemistry 51 (12), 1786-1795 , 2021 2021 Citations: 7
MOST CITED SCHOLAR PUBLICATIONS
Engineering Chemistry GVSR C Rama Chandaraiah, K N Jayaveera Mc Graw Hill 3, 246 , 2009 2009 Citations: 88
Trace metals in vegetables and fruits cultivated around the surroundings of Tummalapalle uranium mining site, Andhra Pradesh, India AM Basha, N Yasovardhan, SV Satyanarayana, GVS Reddy, AV Kumar Toxicology Reports 1, 505-512 , 2014 2014 Citations: 76
Analytical methodologies to detect n-nitrosamine impurities in active pharmaceutical ingredients, drug products and other matrices KM Manchuri, MA Shaik, VSR Gopireddy, N Sultana, S Gogineni Chemical Research in Toxicology 37 (9), 1456-1483 , 2024 2024 Citations: 49
Antibacterial cotton fabrics with in situ generated silver and copper bimetallic nanoparticles using red sanders powder extract as reducing agent A Venkateswara Rao, B Ashok, M Uma Mahesh, G Venkata Subbareddy, ... International Journal of Polymer Analysis and Characterization 24 (4), 346-354 , 2019 2019 Citations: 41
Assessment of heavy metal content of hen eggs in the surroundings of uranium mining area, India AM Basha, N Yasovardhan, SV Satyanarayana, GVS Reddy, AV Kumar Ann Food Sci Technol 1 (1), 344-349 , 2013 2013 Citations: 35
A mild and efficient copper-catalyzed N-arylation of unprotected sulfonimidamides using boronic acids SRK Battula, GV Subbareddy, IE Chakravarthy Tetrahedron Letters 55 (2), 517-520 , 2014 2014 Citations: 31
Differential pulse polarographic determination of dicrotophos, crotoxyphos and chlorfenvinphos in grains and soils NY Sreedhar, PRK Reddy, GVS Reddy, SJ Reddy Talanta 44 (10), 1859-1863 , 1997 1997 Citations: 31
Biosynthesis and study of bimetallic copper and silver nanoparticles on cellulose cotton fabrics using Moringa oliefiera leaf extraction as reductant J Seetha, UM Mallavarapu, P Akepogu, A Mesa, VR Gollapudi, ... Inorganic and Nano-Metal Chemistry 50 (9), 828-835 , 2020 2020 Citations: 29
In situ generation of silver and silver oxide nanoparticles on cotton fabrics using Tinospora cordifolia as bio reductant VR Gollapudi, U Mallavarapu, J Seetha, P Akepogu, VR Amara, ... SN Applied Sciences 2 (3), 508 , 2020 2020 Citations: 27
Formulation Design and in vitro Evaluation of Zolmitriptan Immediate Release Tablets using Primojel and AC-Di-Sol N Panda, AV Reddy, GVS Reddy, KC Panda journal of pharmaceutical sciences and research 7 (8), 545-553 , 2015 2015 Citations: 27
Preparation and properties of silver nanocomposite fabrics with in situ-generated silver nano particles using red sanders powder extract as reducing agent GVSAVR Amara Venkateswara Rao, Basa Ashok, Mallavarapu Umamahesh, Vatti ... International Journal of Polymer Analysis and Characterization 23 (6), 493-501 , 2018 2018 Citations: 24
Electrochemical reduction of flutamide and its determination in dosage forms and biological media GVS Reddy, CLN Reddy, VN Myreddy, SJ Reddy J. Clin. Med. Res 3 (35.1) , 2011 2011 Citations: 21
“Polarographic reduction Behaviour of some potential antibiotic Cephalosporins", G.V.SUBBA REDDY, M. Vijaya Narasimha, and S. Jayarama Reddy International Journal of Pharmacy and Pharmaceutical Science, 2 (4), 190-193 , 2010 2010 Citations: 21
Heterosis in groundnut (Arachis hypogaea L.) V Jayalakshmi, CR Reddy, GLK Reddy Legume Research 23 (3), 155-158 , 2000 2000 Citations: 20
GC-MS analysis and in-vitro anti-diabetic activity of bioactive fractions of Feronia elephantum fruit GJ Reddy, KB Reddy, GS Reddy International Journal of Pharmaceutical Sciences and Research 11 (5), 2415-2424 , 2020 2020 Citations: 19
Baseline survey of trace metals in ambient PM10 at Tummalapalle uranium mining site AM Basha, N Yasovardhan, SV Satyanarayana, GVS Reddy, AV Kumar Atmospheric Pollution Research 5 (4), 591-600 , 2014 2014 Citations: 19
Process optimization, Formulation and evaluation of hydrogel {Guargum-G-Poly (Acrylamide)} based Doxofylline microbeads N Panda, KC Panda, AV Reddy, GVS Reddy Asian Journal of Pharmaceutical and Clinical Research 7 (5), 60-65 , 2014 2014 Citations: 16
Bacterial fauna associating with chironomid larvae from lakes of Bengaluru city, India - A 16s rRNA gene based identification GVSR Ramprasad Kunchama, Thiyagarajan Sivaprakasama, Puneeth KumarR ... Genomics Data 12 (1), 44-48 , 2013 2013 Citations: 15
