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Determination and Validation of HPTLC Method for Cinacalcet Hydrochloride

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American Journal of Analytical Chemistry 2019年第2期10卷 55-64页

作者： swetha Kamatham Ciddi Veeresham University College of Pharmaceutical Sciences Kakatiya University Warangal India

Cinacalcet Hydrochloride (CIN) is a new calcimimetic agent indicated for the use in hypercalcemia. The present work is aimed at development and validation of a novel and simple high-performance thin-layer chromatographic (HPTLC) method for the analysis of Cinacalcet Hydrochloride (active pharmaceutical ingredient, API. In the method, Aluminum-backed silica gel 60 F254 plates (10 × 10 cm) were used as stationary phase and chloroform: acetonitrile (6:4, v/v) as the mobile phase, which showed compact bands of Cinacalcet HCl (RF 0.30 ± 0.02). Quantitative analysis was carried out by densitometry at a wavelength of 282 nm. Linear regression analysis for the calibration spots showed good correlation ship with regression co-efficient r2 = 0.9994 in the range of 40 - 160 ng/band. The developed method suitability for quantification of CIN was learned by validating it as per the ICH guidelines. CIN detection limit was 0.48 ng/band and the quantification limit was 1.59 ng/band. The proposed method was found to be linear (r2 = 0.999), precise (%RSD < 2% for intraday and intermediate precision), accurate, specific, and robust. Further, the developed method was validated and found suitable for stress induced studies, since presence of degradants has no effect on CIN estimation. The proposed method was found to be simple, sensitive, precise, accurate and reproducible for the estimation of CIN.

关键词： Cinacalcet Hydrochloride HPTLC Method Validation Densitometry Forced Degradation

Bioactive polymeric scaffolds for tissue engineering

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Bioactive Materials 2016年第2期1卷 93-108页

作者： Scott Stratton Namdev B.Shelke Kazunori Hoshino swetha Rudraiah Sangamesh G.Kumbar Department of Orthopaedic Surgery UConn HealthFarmingtonCTUSA Institute for Regenerative Engineering UConn HealthFarmingtonCTUSA Department of Biomedical Engineering University of ConnecticutStorrsCTUSA Department of Pharmaceutical Sciences School of PharmacyUniversity of Saint JosephHartfordCT06103USA

A variety of engineered scaffolds have been created for tissue engineering using polymers,ceramics and their *** has been adopted for majority of the three-dimensional(3D)scaffold design both in terms of physicochemical properties,as well as bioactivity for superior tissue *** fabricated via salt leaching,particle sintering,hydrogels and lithography have been successful in promoting cell growth in vitro and tissue regeneration in *** systems derived from decellularization of whole organs or tissues has been popular due to their assured biocompatibility and *** scaffold fabrication techniques often failed to create intricate structures with greater resolution,not reproducible and involved multiple *** 3D printing technology overcome several limitations of the traditional techniques and made it easier to adopt several thermoplastics and hydrogels to create micro-nanostructured scaffolds and devices for tissue engineering and drug *** review highlights scaffold fabrication methodologies with a focus on optimizing scaffold performance through the matrix pores,bioactivity and degradation rate to enable tissue *** highlights few examples of bioactive scaffold mediated nerve,muscle,tendon/ligament and bone *** of the efforts required for optimization,a shift in 3D scaffold uses from the laboratory into everyday life is expected in the near future as some of the methods discussed in this review become more streamlined.

关键词： Bioactive Biomaterials Scaffold Porosity Biodegradable Tissue regeneration

Barriers to achieving a cure in lymphoma

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Cancer Drug Resistance 2021年第4期4卷 965-983页

作者： swetha Kambhampati Joo Y.Song Alex F.Herrera Wing C.Chan Department of Hematology and Hematopoietic Cell Transplantation City of Hope National Medical CenterDuarteCA 91010USA Department of Pathology City of Hope National Medical CenterDuarteCA 91010USA

Lymphoma is a diverse disease with a variety of different subtypes,each characterized by unique pathophysiology,tumor microenvironment,and underlying signaling pathways leading to *** our increasing understanding of the molecular biology of lymphoma,there have been a number of novel targeted therapies and immunotherapy approaches that have been developed for the treatment of this complex *** rapid progress in the field,however,many patients still relapse largely due to the development of drug resistance to these therapies.A better understanding of the mechanisms underlying resistance is needed to develop more novel treatment strategies that circumvent these mechanisms and design better treatment algorithms that personalize therapies to patients and sequence these therapies in the most optimal *** review focuses on the recent advances in therapies in lymphoma,including targeted therapies,monoclonal antibodies,antibody-drug conjugates,cellular therapy,bispecific antibodies,and checkpoint *** discuss the genetic and cellular principles of drug resistance that span across all the therapies,as well as some of the unique mechanisms of resistance that are specific to these individual classes of therapies and the strategies that have been developed to address these modes of resistance.

关键词： Lymphoma drug resistance novel therapies targeted agents immune therapies

Diagnostic accuracy and clinical utility of non-English versions of Edinburgh Post-Natal Depression Scale for screening post-natal depression in India:A meta-analysis

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World Journal of Psychiatry 2020年第4期10卷 71-80页

作者： Paul Swamidhas Sudhakar Russell swetha Madhuri Chikkala Richa Earnest Shonima Aynipully Viswanathan Sushila Russell Priya Mary Mammen Child and Adolescent Psychiatry Unit Department of PsychiatryChristian Medical CollegeVellore 632002India

BACKGROUND The prevalence of post-natal depression(PND)is high in India,as it is in many other low to middle income *** is an urgent need to identify PND and treat the mother as early as *** the many paper and pencil tests available to identify PND,the Edinburgh Postnatal Depression Scale(EPDS)is a widely used and validated measure in ***,the summary diagnostic accuracy and clinical utility data are not available for this *** To establish summary data for the global diagnostic accuracy parameter as well as the clinical utility of the non-English versions of the EPDS in *** Two researchers independently searched the PubMed,EMBASE,MEDKNOW and IndMED databases for published papers,governmental publications,conference proceedings and grey literature from *** studies that evaluated the diagnostic accuracy of EPDS in five Indian languages against DSM/ICD were included in the final *** other investigators extracted the Participants’details,Index measures,Comparative reference measures,and Outcomes of diagnostic accuracy data,and appraised the study quality using ***’s plots were used to evaluate publication *** used the area under the curve of the hierarchical summary area under the receiver operating characteristic curve,with the random effect model,to summarize the global diagnostic accuracy of *** the 2×2 table,we calculated positive and negative likelihood *** the likelihood ratios,the Fagan’s nomogram was built for evaluating clinical utility using the Bayesian *** calculated the 95%confidence interval(95%CI)whenever ***(version 15)with MIDAS and METANDI modules were *** There was no publication *** area under the curve for EPDS was 0.97(95%CI:0.95-0.98).The pre-test probability for the nomogram was 22%.For a positive likelihood ratio of 9,the positive post-test probability was 72%(95%CI:68%,76%)and for a negative LR of 0.08,the negativ

关键词： Clinical-utility Diagnostic-accuracy Edinburgh Postnatal Depression Scale Meta-analysis India Validation

Enantioselective Conversion of Racemic Felodipine to S(-)-Felodipine by Aspergillus niger and Lipase AP6 Enzyme

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Advances in Microbiology 2016年第14期6卷 1062-1074页

作者： Chandupatla Vijitha Ettireddy swetha Ciddi Veeresham University College of Pharmaceutical Sciences Kakatiya University Warangal India

The present study involves the enantioselective resolution of racemic Felodipine by using free and immobilized forms of microbial cultures as well as an enzyme (Lipase AP6). Among the microbial cultures employed in the present study, Aspergillus niger, Sphingomonas paucimobilis, Cunninghamella elegans, Escherichia coli, Pseudomonas putida and Cunninghamella blakesleeana were found to possess capability of enantioselective resolution of racemic Felodipine. The enantiomeric excess (ee%) of Felodipine after reaction catalyzed by whole-cell A. niger and S. paucimobilis was found as 81.59 and 71.67%, respectively. Immobilization enhanced the enantioselectivity (enantiomeric ratio (E)) of the biocatalysts and hence this led to enhanced enantiomeric purity of the drug. The ee% values were found to be enhanced in reactions catalyzed by A. niger and S. paucimobilis cultures after immobilization as 98.27 and 93.56%, respectively. Enantiomeric ratio (E) of the reactions catalyzed by all the biocatalysts has been improved after immobilization. E value of the reaction catalyzed by immobilized A. niger was found to be excellent (E > 100) and hence the drug showed high enantiomeric purity. In lipase AP6 catalyzed study, the enantioselectivity was enhanced after immobilization with excellent E value, which led to enhanced enantiomeric purity of the drug (99.21% ee%).

关键词： Racemic Felodipine Enantioselective Conversion Biocatalysts Immobilization Lipase AP6

Development and Validation of a High Performance Thin Layer Chromatographic Method for Quantitative Analysis of Saxagliptin

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American Journal of Analytical Chemistry 2015年第10期6卷 797-806页

作者： Salvala Srividya Ettireddy swetha Ciddi Veeresham University College of Pharmaceutical Sciences Kakatiya University Warangal India

A simple, specific, accurate and precise high performance thin layer chromatographic method (HPTLC) was developed for the quantitative analysis of Saxagliptin in active pharmaceutical ingredients (APIs) and pharmaceutical dosage forms. The method was achieved using silica gel aluminum plate 60 F254 (10 × 10 cm) as stationary phase and Methanol:Chloroform (6:4 v/v) as mobile phase. The developed plate was scanned densitometrically using UV 222 nm wavelength. The Rf value of Saxagliptin was found to be 0.50 ± 0.02. The developed method was validated according to ICH guidelines. Limit of detection (LOD) and limit of quantification (LOQ) of Saxagliptin by this method were found as 7.96 ng/spot and 26.54 ng/spot, respectively. The method was found to be sensitive, specific, linear, accurate, precise and robust for the quantitative analysis of Saxagliptin in both APIs and marketed tablet formulation.

关键词： HPTLC Saxagliptin Quantitative Analysis Stress Induced Degradation Validation API

HPLC Method Development and Validation of S(-)-Carvedilol from API and Formulations

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American Journal of Analytical Chemistry 2015年第5期6卷 437-445页

作者： Ettireddy swetha Chandupatla Vijitha Ciddi Veeresham University College of Pharmaceutical Sciences Kakatiya University Warangal India

A simple chiral HPLC method was developed and validated for quantification of S(-)-Carvedilol in Active Pharmaceutical Ingredient (API) and marketed tablet formulation of racemic Carvedilol. Chiral resolution of enantiomers of Carvedilol was achieved on Phenomenex Lux-cellulose–4 (250 mm × 4.6 mm;5 μ particle size) chiral column by using a mobile phase, Isopropanol and n-Heptane (60:40 v/v), at a flow rate of 1.0 ml/min and by employing UV detection at 254 nm wavelength. The method was validated according to the ICH guidelines and was proved to be specific, linear, precise and accurate for the analysis of S(-)-Carvedilol.

关键词： S(-)-Carvedilol Chiral HPLC Chiral Resolution API Validation

Pharmacologic therapy for acute pancreatitis

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World Journal of Gastroenterology 2014年第45期20卷 16868-16880页

作者： swetha Kambhampati Walter Park Aida Habtezion Division of Gastroenterology and Hepatology Department of Medicine Stanford University School of Medicine

While conservative management such as fluid,bowel rest,and antibiotics is the mainstay of current acute pancreatitis management,there is a lot of promise in pharmacologic therapies that target various aspects of the pathogenesis of *** review of preclinical studies,which include assessment of therapies such as anti-secretory agents,protease inhibitors,anti-inflammatory agents,and anti-oxidants are *** of these studies have shown therapeutic benefit and improved survival in experimental *** on available preclinical studies,we discuss potential novel targeted pharmacologic approaches that may offer promise in the treatment of acute *** date a variety of clinical studies have assessed the translational potential of animal model effective experimental therapies and have shown either failure or mixed results in human *** these discouraging clinical studies,there is a great clinical need and there exist several preclinical effective therapies that await investigation in *** understanding of acute pancreatitis pathophysiology and lessons learnedfrom past clinical studies are likely to offer a great foundation upon which to expand future therapies in acute pancreatitis.

关键词： Acute pancreatitis Antisecretory Protease inhibito

Biopolymer-nanotube nerve guidance conduit drug delivery for peripheral nerve regeneration:In vivo structural and functional assessment

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Bioactive Materials 2021年第9期6卷 2881-2893页

作者： Ohan S.Manoukian swetha Rudraiah Michael R.Arul Jenna M.Bartley Jiana T.Baker Xiaojun Yu Sangamesh G.Kumbar Department of Biomedical Engineering University of ConnecticutStorrsCTUSA Department of Orthopedic Surgery University of Connecticut HealthFarmingtonCTUSA Department of Pharmaceutical Sciences University of Saint JosephHartfordCTUSA Department of Immunology Center on AgingUniversity of Connecticut HealthFarmingtonCTUSA Department of Biomedical Engineering Stevens Institute of TechnologyHobokenNJUSA

Peripheral nerve injuries account for roughly 3%of all trauma patients with over 900,000 repair procedures annually in the *** all extremity peripheral nerve injuries,51%require nerve repair with a transected *** current gold-standard treatment for peripheral nerve injuries,autograft repair,has several *** constructs are currently only suitable for short gaps or small diameter ***,we investigate novel nerve guidance conduits with aligned microchannel porosity that deliver sustained-release of neurogenic 4-aminopyridine(4-AP)for peripheral nerve regeneration in a critical-size(15 mm)rat sciatic nerve transection *** results of functional walking track analysis,morphometric evaluations of myelin development,and histological assessments of various markers confirmed the equivalency of our drug-conduit with autograft *** nerves showed formation of thick myelin,presence of S100 and neurofilament markers,and promising functional *** conduit’s aligned microchannel architecture may play a vital role in physically guiding axons for distal target reinnervation,while the sustained release of 4-AP may increase nerve conduction,and in turn synaptic neurotransmitter release and upregulation of critical Schwann cell neurotrophic ***,our nerve construct design facilitates efficient and efficacious peripheral nerve regeneration via a drug delivery system that is feasible for clinical applications.

关键词： Peripheral nerve regeneration Nerve guidance conduit Sciatic nerve transection Small-molecule drug delivery Neurotrophic factor Functional recovery