Abstract The objective of the present research work was to demonstrate application liquid chromatography coupled with tandem mass spectrometry (LC‐MS/MS) for separation, identification, and characterization degradation products (DPs) drug lobeglitazone. subjected various stress conditions such as oxidation, hydrolysis, thermal, photolytic per guidelines International Conference on Harmonization Q1A (R2). stable under thermal conditions, whereas it susceptible in other forming four DPs. DPs...

The objective of the present investigation was to separate, identify and characterize degradation products hydrochlorothiazide under hydrolytic, oxidative, photolytic thermal stress conditions as per International Conference on Harmonization (ICH) guideline Q1A (R2). drug degraded acidic, basic, neutral oxidative stress, while it stable conditions. Two were formed, which separated by using HPLC C18 column isocratic elution program. A complete mass fragmentation pathway first established with...

A novel series of 2-Chloroquinoline nucleus clubbed with the pyrazole ring has been synthesized and screened for antibacterial antifungal activity. The results obtained were promising against both bacterial fungal strains. Among series, compound MB - N was found moderately active Aspergillus fumigatus , Penicillium notatum Bacillus subtilis having MIC 48, 46 44 μg/ml, respectively whereas P. B. Escherichia coli 57, 54 43 as compared to standard.

The aim of the present investigation was to demonstrate an approach involving use liquid chromatography (LC) and chromatography-mass spectrometry (LC-MS) separate, identify characterize very small quantities degradation products (DPs) acebutolol without their isolation from reaction mixtures. drug subjected oxidative, hydrolytic, thermal photolytic stress conditions as per International Conference on Harmonization (ICH) guideline Q1A(R2). Among all found be labile in hydrolytic (acidic &...

The COVID-19 pandemic necessitated the emergence of decentralized Clinical Trials (DCTs) due to patient retention, accelerate trials, improve data accessibility, enable virtual care, and facilitate seamless communication through integrated systems. However, integrating systems in DCTs exposes clinical potential security threats, making them susceptible theft at any stage, a high risk protocol deviations, monitoring issues. To mitigate these challenges, blockchain technology serves as secure...

The present work involves synthesis of novel anti-fungal agents containing triazole scaffold. newly designed compounds were synthesized on the trails ketoconazole using molecular hybridization approach. A series 10 having (2-((1H-1,2,4-triazol-1-yl)methyl)-2-(2,4-dichlorophenyl)-1,3-dioxolan-4-yl)methyl esters (4a–j) prepared by conventional synthetic subjected for in vitro screening against Aspergillus niger, fumigatus, Candida albicans and Penicillium notatum. Out compounds, six (4b–f j)...

The objective of the present investigation was to separate, identify and characterize major degradation products olopatadine hydrochloride, an anti-allergic drug, generated under different stress conditions as per International Conference on Harmonization (ICH) guidelines Q1A (R2). drug underwent transformation acidic, basic, photolytic stress, whereas it stable in oxidative thermal conditions. Total five were formed, which separated by using HPLC Inertsil ODS 3 (250 mm × 4.6 mm, 5 µm)...

Abstract The present research work was carried out to determine the stability of erlotinib hydrochloride (ERLO) drug under different stress conditions recommended by International Conference on Harmonization (ICH) guideline Q1A (R2). studied hydrolytic, oxidative, photolytic, and thermal conditions. found susceptible degradation acidic, basic, photolytic conditions, while it stable neutral, A total three products (DPs) were formed. Separation using high-performance liquid chromatography...

In search of novel cytotoxic agents based on acridone scaffold, twenty five derivatives acridone-2- carboxamide were synthesized and evaluated against a panel eleven cancer cell lines by using MTT assay. Amides, A5 A8 (IC50 = 0.3 µM) exhibited good cytotoxicity MCF7. Compound A22 4.3 was found to be selectively line MCF7 KB403. Particularly, promising activities shown amides A6 0.7 µM), A16 6.3 0.9 µM ), A21 1.3 2.9 2.8 A14 0.8 A9 0.4 lines; PA1, WRL68, CaCO2, TK-10, K-562, PC-3, HOP-92,...

Ebastine, a histamine H1 antagonist, nonsedating, belonging to BCS class II is used in the treatment of allergic rhinitis and chronic idiopathic urticaria. The current study was intended augmenting aqueous solubility dissolution rate ebastine, by formulating microemulsion system using oleic acid, Transcutol® HP, Tween®80 as oily phase, cosurfactant, surfactant, respectively, phase titration method. A custom mixture design with optimality D formulation Design Expert® Software (Version 11;...

The objective of present investigation was to develop and validate assay methods for simultaneous estimation quinapril hydrochloride hydrochlorothiazide in combined dosage form by using three different analytical approaches viz.UV, FT-IR RP-HPLC.Drugs were estimated dual wavelength method calibration curve UV spectrophotometer, respectively.The stability indicating developed HPLC.The stress degradation study carried out according International Conference on Harmonization (ICH) guideline Q1A...

Canagliflozin, Dapagliflozin, and Empagliflozin, glucagon-like peptide-1 receptor agonists, are indicated for managing type II diabetes. Although the genotoxicity profiles of these drugs well-explored, limited information exists regarding genotoxic potential their impurities. In this investigation, dimer impurities Empagliflozin underwent both in silico vitro assessments mutagenic potential. Tester strains Salmonella typhimurium Escherichia coli were subjected to Ames test, utilizing...

The COVID-19 pandemic necessitated the emergence of decentralized Clinical Trials (DCTs) due to patient retention, accelerate trials, improve data accessibility, enable virtual care, and facilitate seamless communication through integrated systems. However, integrating systems in DCTs exposes clinical potential security threats, making them susceptible theft at any stage, a high risk protocol deviations, monitoring issues. To mitigate these challenges, blockchain technology serves as secure...

Abstract Background The aim of the present work was to determine potential toxicity degradation products febantel generated under different stress conditions mentioned in guideline Q1A (R2) laid down by International Council for Harmonization (ICH). stability behavior studied subjecting it hydrolytic, oxidative, photolytic and thermal forced conditions. Results Five (DPs) were observed which resolved using high-performance liquid chromatography (HPLC) characterized LC-MS/MS positive mode...

A new process impurity was detected during the HPLC analysis of Tizanidine hydrochloride (I) batches. The (II) isolated by preparative and characterized NMR Mass spectral as 5-S-ethyl-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride.

Abstract The investigation's objective was to access the stability of drug substance Pimozide under stress conditions specified in International Conference on Harmonization Q1A(R2) guideline and separate, identify, characterize degradation products by using liquid chromatography‐tandem mass spectrometry studies without isolating them from reaction mixture. It observed that susceptible oxidative (15% hydrogen peroxide, 48 h, room temperature) forming four novel while being stable hydrolytic,...

In the current scenario, safety aspect related to impurities and their permissible level in formulation has gained worldwide importance. The ICH (International Conference on Harmonization) guidelines official books have addressed this issue critically as it tremendous regulatory implications. present research work addresses above-mentioned for drug riociguat toxicity profiling of its degradation impurities. As per Q1A (R2) guideline, was subjected various stress conditions wherein generated...

The objective of present investigation was to separate, identify, and characterize the degradation products lamotrigine under hydrolytic, oxidative, photolytic, thermal stress conditions as per International Conference on Harmonization (ICH) guideline Q1A (R2). drug underwent acidic, basic, oxidative stress, while it stable in photolytic conditions. A total four were formed which separated by using HPLC C18 column gradient elution program. complete mass fragmentation pattern first...