Journal of Pharmaceutical Analysis and Drug Research ISSN: 3108-0839 (Online)

Authors: Dr. Radhika Sharma, Mr. Siddharth Rao

Abstract: Nanotechnology has revolutionized drug delivery by providing targeted, efficient, and controlled release of therapeutic agents. Analytical methods capable of characterizing nanoparticles, drug loading, release kinetics, and bio-distribution are crucial for the development and quality control of nanomedicine formulations. Techniques such as high-performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC MS), dynamic light scattering (DLS), atomic force microscopy (AFM), and nanoparticle tracking analysis (NTA) enable precise evaluation of nanocarrier systems. This paper reviews the principles, instrumentation, method development, sample preparation strategies, and applications of nanotechnology-based analytical methods in drug delivery systems. Emphasis is placed on the advantages of these methods in ensuring accurate characterization, regulatory compliance, and therapeutic efficacy. Integration of nanotechnology with advanced analytical tools accelerates the development of safe and effective drug delivery systems.

Keywords: Nanotechnology, Drug Delivery, Nanoparticles, Analytical Methods, HPLC, LC-MS, Dynamic Light Scattering, Nanomedicine

Authors: Dr. Pintu B Prajapati, Hitika B. Patel, Dr. Kunjan Bodiwala, Dr. Shailesh Shah

Abstract: Cilnidipine is used for management of hypertension for end-organ protection. A specific, precise, accurate and robust UV-visible spectrophotometric method was developed and validated for stability study of cilnidipine in acidic and alkaline medium.  Forced degradation studies have been carried out in alkaline, acidic and oxidative conditions. The measurement of cilnidipine was carried out at 240 nm. Proposed spectrophotometric method was validated for its accuracy, precision, linearity and range, robustness, specificity as per ICH guideline Q2 (R1). 33 full factorial design was implemented for robustness studies where scanning pitch, scanning speed and wavelength were selected as factors and absorbance was taken as the response for experimental runs suggested by the software. The developed method is linear in the range of 2 to 12 µg/ml with correlation coefficient being 0.9980. The % relative standard deviation for inter and intraday precision were below 2%. Developed method was applied for estimation of Cilnidipine in pharmaceutical dosage form and degradation kinetic study of cilnidipine in acidic and alkaline medium using full factorial design. 32 full factorial design was implemented for determination of relationship between critical variables temperature and strength of acid and alkali with critical quality attributes % degradation, rate constant, half-life. Using response surface mathematical model, % degradation, rate constant and half-life of cilnidipine were predicted at different degradation conditions. The both hydrolytic reactions were found to follow zero order degradation kinetics.

Keywords: stability indicating, cilnidipine, full factorial design, degradation kinetics, UV-Visible spectrophotometry

Authors: Pankaj Singh Patel_, Neha Krishnarth, Ramesh Kr. Gupta, Prashant Kr. Mahopatra

Abstract: The expression "Phyto" signifies plant while "a some" signifies cell-like. Phytosomes are little cell like structure. Phytosomes are conveyance system that are fundamentally similar with liposomes. This is advanced types of herbal formulations which contains the plant bioactive of herbal concentrate encompasses and bound by a lipid. This is a method for better absorption by utilizing plants medication. Phytosomes have the ability to convey the standardized the phytoconstituents through a few routes of drug administration. Presently a day it is a major headway in the field of natural plants.

Keywords:  Plant, Phytoconstituent, Phytosome

Authors: Shabana Khatoon, Dr. Shazia Usmani

Abstract: Diabetes is an important human ailment affecting many from various walks of life in different countries. The limitations of currently-available oral antidiabetic medication either in terms of efficacy and safety coupled with the emergence of the disease into a worldwide epidemic have encouraged effort to discover newer phytomedicines that can be used to manage diabetes more efficiently. Many plants around us have been reported to possess antidiabetic properties. During the last few years, bioactive drugs have been isolated from plants showing anti-diabetic potential. Many studies have been carried out to prove the benefits of medicinal plants with hypoglycemic effects for managing diabetes. Here a list of medicinal plants with proven antidiabetic and related beneficial effects is reviewed and compiled.

Keywords:  Antidiabetic, Hypoglycemic, Clinically, Complications.

Authors : Dr. Ananya Mehta, Dr. Rohan Verma

Abstract: Drug–drug interactions (DDIs) have been recognized as a major factor influencing drug safety and therapeutic outcomes. While most research has focused on interactions at therapeutic or high drug concentrations, emerging evidence suggests that DDIs can also occur at low concentrations, which may be clinically significant, particularly in polypharmacy, chronic therapy, and in populations with altered pharmacokinetics. These interactions often escape detection in conventional in vitro and in vivo studies due to their subtle effects. This review aims to provide a comprehensive discussion on the mechanisms, challenges, and implications of DDIs at low concentrations, emphasizing their clinical relevance, detection strategies, and future research perspectives.

Keywords: Drug–drug interactions, low concentrations, pharmacokinetics, polypharmacy, enzyme inhibition, transporter modulation, clinical relevance

Authors: Dr. Ananya Mukherjee, Dr. Rakesh Sharma

Abstract:  Chemometric and machine learning methods are increasingly applied across diverse scientific and engineering disciplines for data analysis, predictive modeling, and decision-making. While chemometrics primarily focuses on extracting meaningful information from chemical data through statistical and mathematical tools, machine learning enhances this process with computational intelligence and algorithmic adaptability. Together, these methods provide robust frameworks for handling high-dimensional, complex, and noisy datasets. This paper discusses the theoretical foundations of chemometric and machine learning methods, their applications in different fields, comparative strengths, and emerging trends. The challenges and limitations associated with model interpretation, overfitting, data preprocessing, and computational complexity are also highlighted. Finally, the paper explores future prospects in integrating chemometric strategies with machine learning paradigms for advancing research in pharmaceuticals, material science, food chemistry, environmental studies, and bioinformatics.

Keywords: Chemometrics, Machine Learning, Data Analysis, Predictive Modeling, Pattern Recognition, Artificial Intelligence, Multivariate Analysis, Computational Chemistry

Authors : Dr. Ramesh K. Sharma, Dr. Anjali Mehta

Abstract: Three-dimensional (3D) printing has emerged as a transformative technology in pharmaceutical manufacturing, enabling the development of personalized dosage forms tailored to individual patient needs. The ability to customize drug release profiles, dosage strengths, and combination therapies presents an unparalleled opportunity in modern therapeutics. This paper provides a comprehensive overview of the characterization of 3D-printed and personalized dosage forms, focusing on the evaluation techniques, physicochemical properties, mechanical strength, and release kinetics. The review further addresses the challenges associated with 3D-printed pharmaceuticals, including regulatory hurdles, reproducibility concerns, and material limitations, while highlighting the scope for future innovations. The integration of advanced characterization tools ensures that personalized medicines maintain efficacy, safety, and patient compliance, paving the way for a new era in individualized therapy.

Keywords: 3D printing, personalized medicine, dosage forms, characterization, drug delivery, pharmaceutical technology, additive manufacturing

Authors: Dr. Ananya Mehta, Dr. Rohan Choudhary

Abstract: The evolution of novel therapeutic modalities, including monoclonal antibodies, antibody-drug conjugates, oligonucleotides, peptides, cell-based therapies, and gene therapy products, has reshaped the biopharmaceutical landscape. With these advancements, bioanalytical method development has become increasingly critical for understanding pharmacokinetics, pharmacodynamics, immunogenicity, and safety. Unlike traditional small molecules, these complex modalities demand tailored analytical approaches, advanced instrumentation, and innovative strategies to ensure sensitivity, selectivity, reproducibility, and regulatory compliance. This paper discusses the importance of bioanalytical method development for novel modalities, highlights key techniques, outlines challenges, and explores the scope of future innovations in the field.

Keywords: Bioanalytical methods, novel modalities, monoclonal antibodies, oligonucleotides, peptides, gene therapy, immunogenicity, pharmacokinetics, regulatory sciences, analytical validation.

Authors: Anjali Mehta, Dr. Rohit Sinha

Abstract: Spectroscopic imaging and chemical mapping have emerged as transformative techniques in modern scientific research, offering simultaneous spatial and spectral information from complex systems. Unlike conventional imaging methods that provide structural features alone, spectroscopic imaging integrates molecular-level vibrational, electronic, and compositional details, enabling researchers to visualize the chemical architecture of heterogeneous samples. With applications ranging from material sciences to biomedical diagnostics, these methods bridge gaps in understanding molecular distributions, disease progression, drug delivery, and environmental monitoring. Despite remarkable progress in hardware, detectors, and computational approaches, several challenges persist, including high data volumes, interpretation complexities, and limitations in spatial-temporal resolution. This paper provides a comprehensive overview of spectroscopic imaging and chemical mapping, highlighting their fundamental principles, key techniques, research progress, limitations, and potential future scope.

Keywords: Spectroscopic imaging, chemical mapping, vibrational spectroscopy, hyperspectral imaging, material characterization, biomedical diagnostics, molecular mapping.

Authors: Dr. Raghav Mehta, Dr. Priyanka Saxena

Abstract : Trace elements and elemental impurities are present in various pharmaceuticals, food supplements, and environmental matrices at extremely low concentrations. Despite their minimal presence, they can exert significant biological effects, both beneficial and toxic. Accurate detection and quantification of these elements are critical for ensuring human safety and complying with international regulatory standards. This paper provides a comprehensive overview of trace element and elemental impurity analysis, highlighting analytical methodologies, regulatory perspectives, current challenges, and future research scope. It emphasizes the importance of sensitive analytical tools such as ICP-MS, AAS, and XRF in monitoring elemental impurities, and discusses the practical considerations involved in sample preparation, data interpretation, and method validation.

Keywords: Trace elements, elemental impurities, ICP-MS, AAS, pharmaceutical analysis, regulatory compliance, toxicology, analytical methodologies.

Authors: Dr. Kavita R. Menon, Dr. Arvind S. Bhatia

Abstract : The landscape of pharmaceutical science has been revolutionized by the emergence of novel drug modalities, such as biologics, nucleic acid-based therapies, antibody-drug conjugates (ADCs), cell and gene therapies, and nanomedicines. While these advanced modalities offer remarkable therapeutic potential, they also introduce significant analytical challenges due to their complexity, heterogeneity, and structural instability. Analytical scientists are now required to employ cutting-edge methodologies and interdisciplinary approaches to ensure the safety, efficacy, and consistency of these therapeutics. This paper critically examines the analytical challenges associated with novel drug modalities, exploring issues related to characterization, stability assessment, bioassay development, and regulatory compliance. Furthermore, it discusses the evolving analytical landscape, future prospects, and the need for harmonization in analytical standards for next-generation pharmaceuticals.

Keywords: Novel drug modalities, analytical challenges, biologics, nucleic acid therapeutics, cell and gene therapy, antibody-drug conjugates, nanomedicine, bioanalysis, regulatory science.

Authors: Dr. Meenakshi Sharma, Dr. Arvind Kumar

Abstract: Biologics, also known as large molecules, represent a rapidly growing sector of the pharmaceutical industry due to their therapeutic potential, specificity, and ability to target complex disease pathways. Unlike small molecules, biologics such as monoclonal antibodies, recombinant proteins, vaccines, and gene therapies are structurally complex, heterogeneous, and sensitive to production environments. Their analysis requires specialized methodologies that can ensure product quality, safety, and efficacy. The analytical evaluation of large molecules involves multiple stages, including structural characterization, purity assessment, functional testing, and stability studies. This paper provides a comprehensive discussion on the analytical strategies for biologics, highlighting advanced techniques such as mass spectrometry, chromatography, spectroscopy, and bioassays. It further reviews current literature, addresses major challenges in large molecule analysis, and identifies the scope for future advancements in biopharmaceutical development.

Keywords: Biologics, Large molecules, Analytical techniques, Monoclonal antibodies, Mass spectrometry, Chromatography, Biopharmaceutical analysis, Protein characterization, Therapeutic development

Authors: Dr. Rakesh Kumar, Dr. Meenakshi Sharma

Abstract: Artificial Intelligence (AI) and Deep Learning (DL) have revolutionized various scientific domains, including analytical chemistry, pharmaceutical development, and bioprocess optimization. The integration of AI-assisted tools in analytical method development enables enhanced prediction accuracy, reduced experimentation time, and improved reproducibility. Deep learning based predictive algorithms facilitate the modeling of complex analytical processes, including chromatographic separation, spectroscopic interpretation, and multi-parameter optimization. This paper explores the conceptual framework, methodological approaches, and potential of AI and deep learning in predictive analytical performance. Additionally, it highlights current challenges, research gaps, and the evolving scope of AI-driven analytical sciences in precision diagnostics, pharmaceutical quality control, and environmental monitoring.

Keywords: Artificial Intelligence, Deep Learning, Analytical Method Development, Predictive Modeling, Chromatography, Chemometrics, Analytical Performance.

Authors: Dr. Meenakshi Sharma, Dr. Arvind Kumar Singh

Abstract : Nanomedicine represents a revolutionary paradigm in healthcare, promising enhanced drug delivery, improved therapeutic efficacy, and minimal adverse effects. Nanoparticles, as the core components of nanomedicine, possess unique physicochemical properties, allowing them to interact at the molecular and cellular level. Proper characterization of nanoparticles is crucial for determining their safety, stability, and functionality. This review explores the recent advances in nanomedicine, the techniques for nanoparticle characterization, challenges in translating nanotechnology to clinical applications, and the future scope of this interdisciplinary field. Despite tremendous potential, nanomedicine faces obstacles including toxicity concerns, scalability, regulatory hurdles, and reproducibility, which must be overcome to achieve widespread clinical use.

Keywords: Nanomedicine, Nanoparticles, Drug Delivery, Characterization Techniques, Therapeutics, Nanotechnology, Biocompatibility, Targeted Therapy

Authors: Dr. Sneha Rathi, Mr. Arjun Mehta

Abstract: Pharmacokinetic and bioequivalence studies are essential components in the drug development process, ensuring safety, efficacy, and regulatory compliance of pharmaceuticals. These studies evaluate the absorption, distribution, metabolism, and excretion (ADME) of drugs, while bioequivalence studies assess the therapeutic equivalence between generic and reference formulations. Modern analytical tools, including High Performance Liquid Chromatography (HPLC), Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS), Ultra-Performance Liquid Chromatography (UPLC), and immunoassays, have transformed these studies by providing high sensitivity, selectivity, and accuracy. This paper discusses principles, sample preparation, analytical techniques, method validation, and applications of these tools in pharmacokinetic and bioequivalence studies. Integration of hyphenated techniques, automation, and computational approaches enhances throughput and reliability, supporting drug approval and therapeutic monitoring.

Keywords: Pharmacokinetics, Bioequivalence, HPLC, LC-MS/MS, UPLC, ADME, Analytical Methods

Author: Sarika P. Patel

Abstract: A straightforward, quick, touchy and particular Liquid Chromatography couple mass spectrometric technique for the evaluation of quetiapine fumarate in human plasma is depicted. Analyte was chromatographed on excellent essential C18 segment (50×4.6 mm) 3µm [Chromatopack] with isocratic elution at a stream rate of 0.700 ml/moment and Quetiapine-D4 was utilized as the inward standard. The test includes a basic strong stage extraction system of 0.100mL human plasma and the investigation was performed on a triple-quadrupole couple mass spectrometer by MRM mode through electrospray ionization (ESI). The strategy was straight in the focus scope of 1004.176ng/ml - 5.038ng/ml.The inside and between-day exactness and precision of the quality control tests. The recuperation was 1.38 and 1.36 for Quetiapine fumarate and Quetiapine-D4, separately. The investigation time for each example was 2 min. The technique was profoundly reproducible and gave crests with amazing chromatography properties.

Keywords: Quetiapine fumarate, Liquid Chromatography, mass spectrometric method, Schizophrenia, Human Plasma

Authors: Saimar Khan S, Surya S R

Abstract: Precise and accordant detection and prognosis, CAD (computer aided diagnosis) plays a fair role in predicting the outcome of the treatment and planning of the therapy. Detection and segmentation of the cells are the important steps in a CAD. These steps are difficult due to touching cells, untidy background and variation in the shapes of the cell and changes inside the nuclei. In this paper, we present an analysis based on the textual features of the detected cell after the detection of the cell using adaptive dictionary selection and the sparse reconstruction technique with trivial template. The analysis is done on the basis of the first order and second order statistical features. The proposed method has been tested on a data set with 1000 cells extracted from 20 whole slide scanned images.

Keywords: Sparse reconstruction, trivial templates, cell detection

Authors: Lodhi Devendra Singh, Dr.KuldeepGanj, Pradeep Patra

Abstract: Colonic delivery refers to targeted delivery of drugs into the lower GI tract, which occurs primarily in the large intestine (i.e. colon). The site-specific delivery of drugs to lower parts of the GI tract is advantageous for localized treatment of several colonic diseases, mainly inflammatory bowel disease (Crohn’s disease and ulcerative colitis), irritable bowel syndrome, and colon cancerother potential applications of colonic delivery include chronotherapy, prophylaxis of colon cancer and treatment of nicotine addiction.

Keywords: -Prodrug approaches, Azo bond conjugate, Glycoside conjugation Pulsincap diverticulitis

Authors: TanjinSharmily, Md. Shahidul Islam

Abstract: The research work comprises of interaction studies of Ceftriaxone with irbesartan and investigation of antimicrobial activity of Ceftriaxone. Ceftriaxone is included among the Cephalosporin drug class which is active against a wide range of gram positive and negative bacteria. This drug is used to treat many kinds of bacterial infections, including severe or life- threatening forms such as meningitis. Ceftriaxone is also used to prevent infection in people having certain types of surgery. Ceftriaxone interact with antihypertensive drug such as Irbesartan. Irbesartan is used to treat high blood pressure & to protect the kidneys from damage due to diabetes. lowering the blood pressure helps to prevent strokes ,heart attack & kidney problems, Irbesartan belongs to a class of drugs called angiotensin receptor blockers(ARBs). It works by relaxing blood vessels so that the blood can flow more easily.The reaction between Ceftriaxone &Irbesartan were simulated to natural environment. Also the antimicrobial activity of the drug and the complexes were determined. There is an effect of pH on drug-drug complexation. It has observed that Ceftriaxone interacts with Irbesartan on a pH 7.4, the stability constant of these complexes were determined in order to evaluate their possible in vivo implications. This research work confirms that there was a possible interaction between the Ceftriaxone &Irbesartanwhich was confirms by Jobs plot method and by antimicrobial investigation. By antimicrobial investigation it was observed that the zone of inhibition of the drug Ceftriaxone with Irbesartan reduced from 14mm to 10mm. In order to investigate the interaction of Irbesartan with Levofloxacin were elucidated by exploiting various spectrophotometric methods. The ultraviolet studies of these complexes were carried out and compared.

Keywords: -Ceftriaxone, Irbesartan, Complexation, Interaction, job’s Plot, Antimicrobial Study