International Journal of Applied Pharmaceutics最新文献

{"title":"DEVELOPMENT AND VALIDATION OF A SIMPLE AND COST-EFFECTIVE UV SPECTROPHOTOMETRIC METHOD FOR QUANTIFYING LINEZOLID","authors":"Iti Chauhan, Lubhan Singh","doi":"10.22159/ijap.2024v16i3.50556","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50556","url":null,"abstract":"Objective: This study focuses on the development and validation of a sensitive, simple, accurate, precise and cost-effective Ultraviolet-Visible (UV) spectrophotometric method for the quantification of Linezolid, a widely used antibiotic in pharmaceutical formulations.\u0000Methods: The analysis utilized a solvent system comprising 80% water and 20% methanol (v/v). The absorbance of standard solutions was measured and a calibration curve was constructed. Various analytical performance parameters, including linearity, range, precision, accuracy, Limit of Detection (LOD), Limit of Quantification (LOQ) and ruggedness, were determined following the International Conference on Harmonization (ICH) Q2 (R1) guidelines.\u0000Results: The maximum absorption peak (λmax) of Linezolid was determined to be 251 nm in the selected medium. Beer-Lambert’s law was valid in the concentration range of 0.5–9 μg/ml, with a high correlation coefficient (R2) of 0.9955. The proposed method exhibited a recovery ranging from 99.08 to 100.37% with % Relative Standard Deviation (RSD) value consistently below 2%.\u0000Conclusion: The study findings confirm the accuracy, precision and reproducibility of the developed method. Additionally, it is characterized by its simplicity, affordability, and time efficiency. Thus, this method can be effectively employed for the quantification of Linezolid in lipid nanoparticles.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141004183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"MOLECULAR DOCKING DYNAMICS OF SELECTED BENZYLIDENE AMINO PHENYL ACETAMIDES AS TMK INHIBITORS USING HIGH THROUGHPUT VIRTUAL SCREENING (HTVS)","authors":"Koppula Jayanthi, Syed Suhaib Ahmed, Mohd Abdul Baqi, Mohammed AFZAL AZAM","doi":"10.22159/ijap.2024v16i3.50023","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50023","url":null,"abstract":"Objective: Thymidylate kinase (TMK) plays a crucial role in bacterial DNA synthesis by catalyzing the phosphorylation of deoxythymidine monophosphate (dTMP) to form deoxythymidine diphosphate (dTDP). Consequently, this enzyme emerges as a promising target for developing novel antibacterial drugs. However, no antibiotics were reported for this target, especially active against Staphylococcus aureus thymidylate kinase.\u0000Methods: Benzylidene acetamide-based ligands were examined for their potency using the in silico method. These novel ligand structures were built using ChemDraw software. The protein was retrieved from the Research Collaboratory for Structural Bioinformatics Protein Data Bank (RCSB PDB) website. The molecular docking and binding free energy calculation by prime Molecular Mechanics in Generalized Bond Surface Area (MM-GBSA) was performed for selected ligands. A 100 ns molecular dynamic simulation was also performed to assess the stability of the potential ligand as TMK inhibitors.\u0000Results: All ten molecules have shown good glide scores and hydrophobic and hydrogen hydrophobic hydrogen bonding interactions with Arg48, Arg36, and π-π stacking Phe66 in the TMK enzyme (PDB: 4HLC). Among them, N-(2-ethylphenyl)-2-(4-((4-nitrobenzylidene) amino) phenoxy) acetamide molecule had high XP-docking scores of-3.27 kcal/mol based on extra-precision data. Prime Molecular Mechanics in Generalized Bond Surface Area study (MM-GBSA) studies also showed promising binding affinities that are ΔBind (-65.80), ΔLipo (-28.55), and ΔVdW (-55.10). Phe66 amino acid residue maintained continuous connections with the ligand during MD simulation. This ligand showed promising binding affinity with the SaTMK target.\u0000Conclusion: The N-(2-ethylphenyl)-2-(4-((4-nitrobenzylidene) amino) phenoxy) acetamide ligand at the position of the benzene ring displayed nitrogen and oxygen group, thus indicating good potential activity as the inhibitor of TMK to treat antibacterial agents.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"23 27","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141004815","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"REVITALIZING THERAPEUTICS: DRUG REPURPOSING AS A COST-EFFECTIVE STRATEGY FOR DRUG DEVELOPMENT","authors":"Shivani Makhijani","doi":"10.22159/ijap.2024v16i3.49581","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.49581","url":null,"abstract":"The process of developing new drugs is known for being drawn-out, expensive, risky, and having a high attrition rate. Drug repurposing has grown in favor recently as a practical way to speed up the development of new medicines while reducing the costs and time constraints associated with traditional drug research. The description of this study's pharmacological repurposing highlights its promise as a practical method to fill gaps in the market and revitalize treatment options. This review provides a full analysis of the ground-breaking tactic of repurposing medications, supported by numerous cases that demonstrate its revolutionary potential. We examine instances of repurposed drugs, such as thalidomide, sildenafil, and metformin, that have performed astoundingly well in a range of therapeutic settings despite being used outside of their original scope.\u0000Overall, the paper's main goal-to study pharmacological repurposing as a potentially successful strategy for revitalizing treatments-is, succinctly summarized in this abstract. It highlights the potential benefits of this approach and how it might be used in the pharmaceutical industry's ongoing quest for more inexpensive and effective medicine development.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"92 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141004210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FORMULATION DEVELOPMENT AND IN VITRO PENETRATION TEST OF ETHOSOME OF CHROMOLAENA ODORATA LEAVES EXTRACT","authors":"Sofia Rahmi, Julia Reveny, Anayanti Arianto, P. Sitorus","doi":"10.22159/ijap.2024v16i3.49856","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.49856","url":null,"abstract":"Objective: This study aimed to develop and assess ethosome preparation using extracts derived from the leaves of Chromolaena odorata.\u0000Methods: The study started by obtaining Chromolaena odorata leaf extracts. Furthermore, Ethosome formulations were produced using a thermal technique. Ethosome variants were created, each with distinct compositions: Formulation F1, containing 10 ml of ethanol without the extract; Formulation F2, consisting of 0.5 grams of the extract mixed with 10 ml of ethanol; Formulation F3, combining 1 gram of the extract with 20 ml of ethanol; and Formulation F4, incorporating 1.5 grams of the extract with 30 ml of ethanol. The ethosomal systems were thoroughly characterized using various analytical techniques, such as organoleptic analysis, quantification of particle dimensions, zeta potential evaluation, pH metric analysis, transmission electron microscopy (TEM) imaging, and in vitro permeability assessment using the Franz Diffusion Cell apparatus.\u0000Results: The findings indicated that the optimized F4 formulation showed 161.2±32.0 nm particle size measurement and a+34.33±0.58 mV zeta potential. All formula possess a pH range of 4.5-6.5, within which the skin can acclimate to preparations. It is evident from all formulations that the pH decreased after the addition of the extract at an acidic pH of 4.11. Following the 12-week storage period, the pH of all treatments exhibited a modest reduction; however, it remained within the acceptable range for skin pH. Furthermore, the F4 formula also had a higher level of penetration activity.\u0000Conclusion: The optimized ethosomal formulations of Chromolaena odorata have promising applications in enhancing the permeability and efficacy of plant-derived therapeutic agents.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"138 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141002649","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DESIGN, DEVELOPMENT AND IMPROVEMENT OF AN EMULGEL CONTAINING SILVER NANOPARTICLES AND VITAMIN D-3 FOR ITS POTENTIAL TO ACCELERATE THE HEALING OF WOUND","authors":"Rishu Yadav, Narendra Kumar Pandey, Rajiv Kukkar","doi":"10.22159/ijap.2024v16i3.50344","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50344","url":null,"abstract":"Objective: The aim of this research work was to prepare a topical emulgel based dosage form incorporated with vitamin D-3 and silver nanoparticles to reduce the wound healing time in any kind of wound.\u0000Methods: Central Composite Design (CCD) was applied for the optimization of emulgel by using Design expert software. Three responses (pH, viscosity, and in vitro drug release) and two factors (Carbopol concentration and stirring duration) were chosen, and Statistical Analysis of Variance (ANOVA) revealed that all the factors were significantly affecting the responses. Silver Nanoparticles (SNPs) was prepared with Green Tea Extract (GTE) and evaluated for particle size, Poly Dispersity Index (PDI), zeta potential and Fourier Transform Infra-red (FTIR) spectroscopy and revealed that SNPs of desired range and stability have been synthesized. Here excision wound model was used to evaluate the wound healing activity of formulation in vivo.\u0000Results: Maximum in vitro release 88.2±2.1 has shown by the optimized formulation F13, pH and viscosity were also found in optimum range i.e., 6.2±0.4 and 1672±33 respectively, followed by Korsmeyer and Peppas model. Total eight groups were designed for animal study and silver sulphadiazine was used as marketed formulation. F13 formulation was further evaluated for in vivo data, it was revealed that emulgel loaded with high dose of vitamin D-3 along with silver nanoparticles has shown 100.5±1.7% wound contraction, while marketed formulation has shown 103.7±1.1% wound contraction, which was much similar with test formulation. Cytotoxic cell study was done using assay on chicken egg, formulation has not shown any cytotoxic behaviour like haemolysis and cell damage on chick embryo’s blood vessels. Accelerated stability study of the optimized formulation was also performed to check whether the formulation was stable or not and it was revealed that optimized formulation was found stable for the period of six months.\u0000Conclusion: It was revealed that emulgel loaded with high dose of vitamin D-3 and SNPs found suitable to accelerate wound healing and showed almost similar response in wound contraction on comparison with marketed formulation. This emulgel promised to controlled the delivery of the drug for the longer duration.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"24 31","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141004850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF CURCUMIN AND RESVERATROL IN NANO-MICELLE: DUAL DRUG DUAL FORM SIMULTANEOUS ESTIMATION","authors":"SK Mosiur Rahaman, Atanu Chandra, Ranu Biswas","doi":"10.22159/ijap.2024v16i3.50276","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50276","url":null,"abstract":"Objective: To develop a reverse-phase high-performance liquid chromatography (RP-HPLC) method for simultaneous estimation of conjugated form of Curcumin (CCMN) and free form of Resveratrol (RSV) in nano-micelle.\u0000Methods: The conjugation of lipophilic CCMN and hydrophilic Chitosan (CHT) through succinyl linker produce amphipathic molecule that can self-assemble into RSV solution to form micelle. Here RSV exists in micelle core as free form and CCMN with micelle backbone as conjugated form. So it required to estimate conjugated drug and free drug simultaneously from nano-micelle. We developed a RP-HPLC method, utilized C18 column, follow flow rate of mobile phase 1.0 ml/min, which consist of acetonitrile with water (0.5% Ortho Phosphoric acid, pH 4.6) in the ratio of 1:1 for 20 min. Injection volume was 10μl and column temperature 25 ℃. Isosbestic detection of both drugs was at 254 nm.\u0000Results: The retention time of RSV and CCMN were at 8.15 min and 11.41 min respectively, completely distinguished sharp peak of CCMN and RSV developed with resolution 7.360±0.117, wide range of linearity with correlation coefficient value (R2) of CCMN and RSV were 0.99987 and 0.99992 respectively and recovery value of CCMN and RSV were 100.041±0.22 % and 100.041±0.21 % respectively. The RSD (relative standard deviation) for accuracy, precision and robustness of the method was found to be less than 2%.\u0000Conclusion: The develop method for simultaneous estimation of conjugated CCMN and free form of RSV in the nano-micelle formulation was consider to be accurate, precise, robust and sensitive.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"87 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141002257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"DEVELOPMENT OF MYCROCRYSTALLINE CELLULOSE ORIGINATE FROM SAGO (METROXYLON SAGU) STEM BARK BY HYDROLISIS METHODE USING NITRIC ACID","authors":"Nur Illiyyin Akib, Sriwidodo, Adryan Fristiohady Lubis, Mery Dina SYNTIA SAMANI, Ahmad FAHMI NUR, Rina Andriani, A. Chaerunisaa","doi":"10.22159/ijap.2024v16i3.49622","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.49622","url":null,"abstract":"Objective: Microcrystalline cellulose (MCC) is an essential excipient in tablet formulation. Mostly MCC was obtained from wooden conifer stem fiber, therefore environment issues had been came up. Alternative sources for MCC which offer friendly conifer wood need to be explored. This study aimed to isolate and determine the characteristics of MCC originated from Sago (Metroxylon sago Rottb.) stem fibers as an promising alternative of MCC.\u0000Methods: MCC was prepared through pre-hydrolysis using an acetic acid solution, alkali heating using NaOH solution, and acid hydrolysis using nitric acid 0.3 N using three variations of heating temperature, namely 90, 95 and 100 °C. The characterization carried out were pharmaceutical grade, powder properties, FTIR analysis and powder morphology by SEM.\u0000Results: The yields obtained were 66.02; 65.53 and 65.08%, respectively. The characteristics of the MCC sample based on pharmaceutical grade quality were white to yellowish white powder, odorless, tasteless, insoluble in: ether, 96% alcohol, HCl 2N and NaOH 1N. The pH of the MCC suspension were 5.07-5.12, while moisture content were 3.67-4.17%, with loss on drying value as much as 0.37-0.4%, and ash content 1-2.17%. The value of permanganate number were 0.09-0.11, Hausner factor was between 1.05-1.25, and angle of repose were between 11.4-24.8°.\u0000Conclusion: Based on the results, it can be concluded that Sago is potent natural resource for MCC. The resulting MCC revealed physicochemical and characteristic of MCC, which almost similar to Avicel PH 102 as standard.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"7 14","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141005064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"BIOLOGICAL REACTIONS OF MACROPHAGES TO METAL OXIDE NANOPARTICLES","authors":"Mohammed Zorah, Hassan Lafta Atiyah, Noor WATHTHAB ALI, R. K. Mohammed Jawad, Fatimah H. Zayed, Mustafa Mudhafar, A. H. A., Saif Ahmed Raheem","doi":"10.22159/ijap.2024v16i3.49928","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.49928","url":null,"abstract":"In our daily lives, nanomaterials are utilized extensively in paints, textiles, food goods, cosmetics, and medicine. Several investigations aim to deter investigations of the physiological effects in various cell types. The innate immune system's macrophages regulate a wide range of biological functions. Depending on the stimulus, macrophages can be activated toward pro- or anti-inflammatory (M1) phenotypes; however, polarization may change in conditions including cancer, autoimmune illnesses, and bacterial and viral infections. Metal oxide nanoparticles have recently gained significant interest due to their diverse range of unique features with applications in research and industry. The production and usage of nanomaterials will rise significantly as the nanotechnology business grows. As a result, testing the consequences of nanomaterial exposure in biological systems is critical. A comparative analysis is conducted on the toxicities of several metal oxide nanoparticles. The significance of biogenically generated metal oxide nanoparticles has been growing in recent years. However, more research is needed to thoroughly characterize the potential toxicity of these nanoparticles to ensure nanosafety and consider environmental views. To that end, nanotoxicology seeks to assess the toxicity of nanomaterials to physicochemical factors such as size and form. In this review, we focus on the biological reactions of macrophages to metal oxide nanoparticles. Because macrophages are the first cells to engage with nanoparticles when they enter the body, they can absorb them through various processes.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"63 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141003220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ANTIBIOTICS IN INDONESIA: ACCESS, WATCH, AND RESERVE CLASSIFICATION","authors":"Dirgahayuni Sari Agustina, Ambarita, P. Oktamianti, I. Gusti, Ayu Trisnadewi, Dirgahayuni Sari, Agustina Ambarita","doi":"10.22159/ijap.2024v16i3.50351","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50351","url":null,"abstract":"Objective: The objective of this study is to compare antibiotics listed in the National Essential Medicines List (NEML) and national formulary in Indonesia by determining the proportion of antibiotics in the three groups, Access, Watch, and Reserve (AWaRe), along with median data, range values, and time trends from 2013 to 2021.\u0000Methods: We obtained the compilation of antibiotics from the NEML and national formulary in Indonesia, covering the period from 2013 to 2021. These antibiotics were evaluated according to the 2021 WHO AWaRe classification database. This analysis involved determining the proportion of antibiotics in the AwaRe groups within each healthcare facility. Median data and range values for these antibiotics were also calculated. Trends in the proportion of AWaRe antibiotics were analyzed and visualized using a line chart.\u0000Results: The Indonesian NEML includes 20 antibiotics, categorized into two tiers of healthcare settings. Of these antibiotics, 13 were access, seven were watch, and there was neither a reserve nor a not recommended antibiotic. The Indonesian national formulary includes 42 antibiotics, categorized into three tiers of healthcare settings. Of these antibiotics, 19 were access, 22 were watch, one was not recommended, and there was no reserve antibiotic. The proportion of antibiotics during the pre-and post-establishment of the WHO AWaRe in 2017 showed significant changes in the Indonesian national formulary but not in the NEML.\u0000Conclusion: In recent years, the proportions of antibiotics in the Indonesian NEML and national formulary have varied according to the WHO AWaRe classification.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"110 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141003702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"IDENTIFICATION, SEPARATION, AND CHARACTERIZATION OF DEGRADATION PRODUCTS OF TRIAMCINOLONE HEXACETONIDE USING LC AND LC-MS/MS","authors":"Bhavna SUNIL MAHAJAN, P. Miniyar","doi":"10.22159/ijap.2024v16i3.50122","DOIUrl":"https://doi.org/10.22159/ijap.2024v16i3.50122","url":null,"abstract":"Objective: The study aimed to separate the forced degradation products of Triamcinolone hexacetonide using HPLC and characterize the degradation product by LC-MS/MS fragmentation pattern.\u0000Methods: Triamcinolone hexacetonide (THA) and its primary degradation products were identified using a liquid chromatography-mass spectrometry/Mass spectrometry (LC-MS/MS) approach. The degradation study was based on in-depth stress testing with acid, base, peroxide, heat, and light. A Zorbax SB C18 column and a greener mobile phase composed of methanol and 10 mmol ammonium acetate buffer in water at pH 3 were employed to accomplish separation and quantitation at a flow rate of 0.7 ml/min in an isocratic mode with a 239 nm detection wavelength.\u0000Results: A major degradation product of the drug was obtained in acidic and alkaline stress conditions. The drug was found to be stable for all other stress conditions. The LC-MS/MS analysis results of the active pharmaceutical ingredient and resulting product after degradation were interpreted to identify the novel degradation product and fragments. The developed method was validated as per International Council for Harmonization (ICH) guidelines. The square root of the correlation coefficients, which indicated linearity for THA in 50 to 150 % of the workload, was 0.99. Method Precision assay was performed on six different preparations, percentage relative standard deviation (% RSD) of assay value is 0.17 % and system precision is 0.30 %. In accuracy, overall % RSD of 50 %, 100 %, and 150 % in triplicate is 0.95.\u0000Conclusion: It is concluded that the drug is stable to all other stress conditions except for acidic and alkaline stress conditions and generates a novel degradation product. The developed LC (Liquid chromatography) method separates and identifies the degradation product.","PeriodicalId":13737,"journal":{"name":"International Journal of Applied Pharmaceutics","volume":"28 31","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141004382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}