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Determination of asenapine in presence of its inactive metabolites in human plasma by LC-MS/MS

Journal of Pharmaceutical Analysis 2018年第5期8卷 341-347页

作者： nirav r patel Mallika Sanyal Naveen Sharma Dinesh S.patel Pranav S.Shrivastav Bhavin N.patel Bioanalytical Laboratory Uiantha Research India Ltd.BodakdevAhmedabad 380054GujaratIndia Kadi Sarva Viswavidyalaya Sector-15Ghandhinagar 382715GujaratIndia Department of Chemistry St.Xavier's CollegeNavrangpuraAhmedabad 380009GujaratIndia Department of Chemistry School of SciencesGujarat UniversityNavrangpuraAhmedabad 380009GujaratIndia

A highly selective and sensitive liquid chromatography-tandem mass spectrometry （LC-MS/MS） assay has been described for the determination of asenapine （ASE） in presence of its inactive metabolites N-desmethyl asenapine （DMA） and asenapine-N-glucuronide （ASG）. ASE, and ASE 13C-d3, used as internal standard （IS）, were extracted from 300 μL human plasma by a simple and precise liquid-liquid extraction procedure using methyl tert-butyl ether. Baseline separation of ASE from its inactive metabolites was achieved on Chromolith Performance rPse （100 mm ×4.6 mm） column using acetonitrile- 5.0 mM ammonium acetate-10% formic acid （90：10：0.1, v/v/v） within 4.5 min. Quantitation of ASE was done on a triple quadrupole mass spectrometer equipped with electrospray ionization in the positive mode. The protonated precursor to product ion transitions monitored for ASE and ASE 13C-d3 were m/z 286.1 → 166.0 and m/z 290.0 → 166.1, respectively. The limit of detection （LOD） and limit of quantitation （LOQ） of the method were 0.0025 ng/mL and 0.050 ng/mL respectively in a linear concentration range of 0.050-20.0 ng/mL for ASE. The intra-batch and inter-batch precision （% CV） and mean relative recovery across quality control levels were 〈 5.8% and 87.3%, respectively. Matrix effect, evaluated as IS-normalized matrix factor, ranged from 1.03 to 1.05. The stability of ASE under different storage conditions was ascertained in presence of the metabolites. The developed method is much simpler, matrix free, rapid and economical compared to the existing methods. The method was suc- cessfully used for a bioequivalence study of asenapine in healthy Indian subjects for the first time.

关键词： Asenapine Asenapine 13C-d3 Metabolites LC-MS/MS Bioequivalence study Human plasma

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review of heart transplantation from hepatitis C-positive donors

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World Journal of Transplantation 2022年第12期12卷 394-404页

作者： Palak patel nirav patel Fahad Ahmed Jason Gluck Department of Cardiology West Roxbury VA CenterWest RoxburyMA 02132United States Department of Cardiology University of ConnecticutHarford HospitalHartfordCT 06102United States Department of Cardiology University of CaliforniaCA 90065United States Department of Internal Medicine Hartford HospitalHartfordCT 06106United States Advanced Heart Failure Hartford HospitalHartfordCT 06102United States

Significant scarcity of a donor pool exists for heart transplantation(HT)as the prevalence of patients with end-stage refractory heart failure is increasing *** the discovery of effective direct-acting antiviral and favorable short-term outcomes following HT,the hearts from hepatitis C virus(HCV)patient are being utilized to increase the donor ***-term outcomes with regards to graft function,coronary artery vasculopathy,and kidney and liver disease is comparable in HCV-negative recipients undergoing HT from HCVpositive donors compared to HCV-negative donors.A significant high incidence of donor-derived HCV transmission was observed with great success of achieving sustained viral response with the use of direct-acting *** accepting HCV-positive organs,the donor pool has expanded with younger donors,a shorter waitlist time,and a reduction in waitlist ***,the longterm outcomes and impact of specific HCV genotypes remains to be *** reviewed the current literature on HT from HCV-positive donors.

关键词： Heart transplant Hepatitis C-positive donors Direct-acting antiviral Coronary allograft vasculopathy Allograft rejection

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Central venous catheterization-related complications in a cohort of 100 hospitalized patients:An observational study

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Journal of Acute Disease 2023年第4期12卷 169-172页

作者： reena Singh Naimish patel Nidhi Mehta Gaurav Singh nirav patel Department of Internal Medicine Sri Aurobindo Institute of Medical ScienceIndore-453555Madhya PradeshIndia Department of Internal Medicine G.C.S Medical College Hospital and Research CentreAhmedabad-380025GujaratIndia Department of Cardiology Sri Aurobindo Institute of Medical ScienceIndore-453555Madhya PradeshIndia

Objective:To evaluate the complications of central venous catheterization(CVC).Methods:A prospective,observational study was conducted at a tertiary care center in India from December 2018 to September *** ill patients(aged≥18 years)in the intensive care unit undergoing CVC procedures were included in the *** demographics and detailed medical history were *** X-rays and electrocardiography were performed on all the *** associated with CVC were ***:A total of 100 patients with the indication for central venous catheter insertion were *** majority(81%)of the patients were inserted with CVC at the right internal jugular *** such as arterial puncture(2%),hematoma(4%),blood clot formation(4%),catheter kinking(3%),thoracic injury(1%),thrombophlebitis(6%),sepsis(9%)and nerve injury(1%)were ***:Though central venous access is preferred in management of critically ill patients,it has its ***,early recognition and prompt management of complications may reduce mortality and *** and intensive care unit intensivists should be vigilant for central venous catheter-related *** site selection,operator experience,and proper catheter maintenance are associated with optimal outcomes.

关键词： Central venous catheter Complications Central line Central venous access Critical care Internal jugular vein

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Synthesis,characterization and antimicrobial activity of some new biquinoline derivatives containing a thiazole moiety

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Chinese Chemical Letters 2012年第4期23卷 454-457页

作者： nirav K.Shah Nimesh M.Shah Manish P.patel ranjan G.patel Department of Chemistry Sardar Patel UniversityVallabh Vidyanagar 388120GujaratIndia

A series of new biquinoline derivatives containing a thiazole moiety were synthesized by a one-pot,base-catalyzed cyclocondensation reaction of 2-chloro-3-formyl quinoline,malononitrile and *** the synthesized compounds were characterized by elemental analysis,FT-Ir,~1H NMr and ^（13）C NMr *** the synthesized compounds were screened against three bacterial pathogens,namely Bacillus cereus,*** and Escherichia coli and for antifungal activity against three fungal pathogens,Aspergillus niger,Fusarium oxisporum and rhizopus using the disc diffusion method.

关键词： Quinoline Multicomponent reaction Thiazole Antimicrobial activity

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Highly sensitive LC–MS/MS method to estimate doxepin and its metabolite nordoxepin in human plasma for a bioequivalence study

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Journal of Pharmaceutical Analysis 2018年第6期8卷 378-385页

作者： nirav P.patel Mallika Sanyal Naveen Sharma Dinesh S.patel Pranav S.Shrivastav Bhavin N.patel Bio-Analytical Laboratory Cliantha Research India Ltd.BodakdevAhmedabad 380054GujaratIndia Kadi Sarva Viswavidyalaya Sector-15Ghandhinagar 382715GujaratIndia Department of Chemistry St.Xavier's CollegeNavrangpuraAhmedabad 380009GujaratIndia Department of Chemistry School of SciencesGujarat UniversityNavrangpuraAhmedabad 380009GujaratIndia

A selective, sensitive and rugged liquid chromatography–tandem mass spectrometry(LC–MS/MS) assay has been developed for the simultaneous determination of doxepin(Dox) and its pharmacologically active metabolite, nordoxepin(NDox) in human plasma. The analytes and their internal standards(IS)were extracted from 500 m L of human plasma by liquid-liquid extraction using methyl tert-butyl *** separation was achieved on Hypurity C8 column(100 mm ? 4.6 mm, 5 mm) using a mixture of acetonitrile-methanol(95:5, v/v) and 2.0 mM ammonium formate in 93:7(v/v) ratio. Detection was accomplished by tandem mass spectrometry in the positive ionization and multiple reaction monitoring acquisition mode. The protonated precursor to product ion transitions studied for Dox, NDox,and their corresponding ISs, propranolol and desipramine, were m/z 280.1-107.0, 266.0-107.0,260.1-116.1 and 267.1-72.1, respectively. A linear dynamic range of 15.0–3900 pg/mL for Dox and 5.00–1300 pg/mL for NDox was established with mean correlation coefficient(r2) of 0.9991 and 0.9993, respectively. The extraction recovery ranged from 86.6%–90.4% and 88.0%–99.1% for Dox and NDox, respectively. The intra-batch and inter-batch precision(% CV) across quality control levels was r 8.3% for both the analytes. Stability evaluated under different storage conditions showed no evidence of degradation and the % change in stability samples compared to nominal concentration ranged from 4.7% to12.3%. The method was successfully applied to a bioequivalence study of 6 mg doxepin hydrochloride orally disintegrating tablet in 41 healthy Indian subjects under fasting and fed conditions.

关键词： Doxepin Nordoxepin LC–MS/MS Liquid-liquid extraction Human plasma Bioequivalence study

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MicrorNAs in pathogenesis of breast cancer:Implications in diagnosis and treatment

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World Journal of Clinical Oncology 2014年第2期5卷 48-60页

作者： nirav r Shah Hexin Chen Department of Biological Science Center for Colon Cancer Research University of South Carolina

Micror NAs(mir NAs) are small non-coding rNAs generated by a two-step complex process and are post transcriptional negative regulators of their target m rNAs. Dysregulation of many of these mir NAs has been associated with tumorigenesis in various cancers including breast cancer. Aberrantly high expression of specific mi rNAs in breast cancer cells is demonstrated to be linked with inhibition of tumor suppressor genes and promote tumorigenesis. They are classified as oncogenic mir NAs. However, the tumor suppressor mir NAs are downregulated in breast cancer cells, since their major targets are oncogenic m rNAs. Understanding mechanism of action of specific mir NAs in breast cancer cells can be utilized to develop newer anti-cancer therapies. recently, newer techniques are also developed to detect abundance of specific mir NA in the blood plasma samples and can be used in early diagnosis or prognosis in breast cancer. In this review article, we have discussed several mi rNAs dysregulated in breast cancer and their therapeutic potential.

关键词： MicrorNAs Breast cancer Cancer stem cells Diagnostic markers Drug resistance

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Is Entresto good for the brain?

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World Journal of Cardiology 2017年第7期9卷 594-599页

作者： nirav patel Jason Gluck Department of Cardiology University of ConnecticutHarford HospitalHartfordCT 06102United States

The main stay pharmacotherapy for heart failure(HF) is targeted towards rennin-angiotensin-aldosterone(rAAS) and neprilysin pathways(NP). Both therapeutic strategies decreases morbidity and mortality but also carry considerable adverse effects. This review of the literature highlights the new generation of HF drug, sacubitril-valsartan(SV), trade name Entresto(researched as LCZ696, Novartis) which simultaneously blocks rAAS and NP. This dual action of angiotensin receptors blocker and neprilysin inhibitor(NPi) has improved HF prognosis and it is an evolution in the management of HF. Although the initial follow-up of patients treated with SV has yielded promising results, there are concerns regarding potential side effects especially an increase in the risk of Alzheimer's disease(AD) and young onset of AD. NPi interferes with the breakdown and clearing of beta-amyloid peptides, the plaques seen in AD, raising concern for AD in SV patients. On the other hand, hypertension and cardiovascular diseases are established risk factors for AD which can be decreased by SV therapy. It is therefore essential that SV treated patients are followed up over an extended period of time to detect any adverse cognitive changes.

关键词： Heart failure Sacubitril-valsartan Entresto LCZ696 Neprilysin inhibitor Alzheimer’s disease

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Fragility of statistically significant findings from randomized clinical trials of surgical treatment of humeral shaft fractures:A systematic review

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World Journal of Orthopedics 2022年第9期13卷 825-836页

作者： Stephen Craig Morris Anirudh K Gowd Avinesh Agarwalla Wesley P Phipatanakul nirav H Amin Joseph N Liu Department of Orthopaedic Surgery Loma Linda UniversityLoma LindaCA 92354United States Department of Orthopaedic Surgery Wake Forest University Baptist Medical CenterWinston-SalemNC 27157United States Department of Orthopaedic Surgery Westchester Medical CenterValhallaNY 10595United States Department of Orthopaedic Surgery Premier Orthopaedic and Trauma SpecialistsPomonaCA 91767United States Department of Orthopedic Surgery USC Epstein Family Center for Sports MedicineLos AngelesCA 90089United States

BACKGrOUND Despite recent meta-analyses of randomized controlled trials(rCTs),there remains no consensus regarding the preferred surgical treatment for humeral shaft *** fragility index(FI)is an emerging tool used to evaluate the robustness of rCTs by quantifying the number of participants in a study group that would need to switch outcomes in order to reverse the study *** To investigate the fragility index of randomized control trials assessing outcomes of operative fixation in proximal humerus *** We completed a systematic review of rCTs evaluating the surgical treatment of humeral shaft *** criteria included:articles published in English;patients randomized and allotted in 1:1 ratio to 2 parallel arms;and dichotomous outcome *** FI was calculated for total complications,each complication individually,and secondary surgeries using the Fisher exact test,as previously *** Fifteen rCTs were included in the analysis comparing open reduction plate osteosynthesis with dynamic compression plate or locking compression plate,intramedullary nail,and minimally invasive plate *** median FI was 0 for all parameters *** individual outcomes,the FI was 0 for 81/91(89%)of *** FI exceeded the number lost to follow up in only 2/91(2%)*** The FI shows that data from rCTs regarding operative treatment of humeral shaft fractures are fragile and does not demonstrate superiority of any particular surgical technique.

关键词： Humerus fracture Open reduction internal fixation Intramedullary nail Fragility index Complications Fragility index

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Multifunctional stimuli responsive polymer-gated iron and gold-embedded silica nano golf balls:Nanoshuttles for targeted on-demand theranostics

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Bone research 2017年第4期5卷 343-356页

作者： Liping Wang Grace Jang Deependra Kumar Ban Vrinda Sant Jay Seth Sami Kazmi nirav patel Qingqing Yang Joon Lee Woraphong Janetanakit Shanshan Wang Brian P Head Gennadi Glinsky ratneshwar Lai School of Biomedical Engineering Shanghai Jiaotong UniverityShanghaiChina Department of Mechanical and Aerospace Engineering La JollaCAUSA Materials Science and Engineering Program La JollaCAUSA Department of Nanoengineering La JollaCAUSA Department of Chemical Engineering University of California San DiegoLa JollaCAUSA Departrnenf of Bioengineering La JollaCAUSA Department of Anesthesiology La JollaCAUSA Veterans Affairs San Diego Healthcare System San DiegoCAUSA Institute of Engineering in Medicine La JollaCAUSA

Multi-functional nanoshuttles for remotely targeted and on-demand delivery of therapeutic molecules and imaging to defined tissues and organs hold great potentials in personalized medicine, including precise early diagnosis, efficient prevention and therapy without toxicity. Yet, in spite of 25 years of research, there are still no such shuttles available. To this end, we have designed magnetic and gold nanoparticles （NP）-embedded silica nanoshuttles （MGNSs） with nanopores on their surface. Fluorescently labeled Doxombicin （DOX）, a cancer drug, was loaded in the MGNSs as a payload. DOX loaded MGNSs were encapsulated in heat and pH sensitive polymer P（NIPAM-co- MAA） to enable controlled release of the payload. Magnetically-guided transport of MGNSs was examined in：（a） a glass capillary tube to simulate their delivery via blood vessels; and （b） porous hydrogels to simulate their transport in composite human tissues, including bone, cartilage, tendon, muscles and blood-brain barrier {BBB）. The viscoelastic properties of hydrogels were examined by atomic force microscopy （AFM）. Cellular uptake of DOX- loaded MGNSs and the subsequent pH and temperature-mediated release were demonstrated in differentiated human neurons derived from induced pluripotent stem cells （iPSCs） as well as epithelial HeLa cells. The presence of embedded iron and gold NPs in silica shells and polymer-coating are supported by SEM and TEM. Fluorescence spectroscopy and microscopy documented DOX loading in the MGNSs. Time-dependent transport of MGNSs guided by an external magnetic field was observed in both glass capillary tubes and in the porous hydrogel. AFM results affirmed that the stiffness of the hydrogels model the rigidity range from soft tissues to bone. pH and temperature-dependent drug release analysis showed stimuli responsive and gradual drug release. Cells＇ viability MTT assays showed that MGNSs are non-toxic. The cell death from on-demand DOX release was observed in both neurons and ep

关键词： Multifunctional stimuli responsive polymer-gated iron

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Escalating complexity of endoscopic retrograde cholangiopancreatography over the last decade with increasing reliance on advanced cannulation techniques

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World Journal of Gastroenterology 2020年第41期26卷 6391-6401页

作者： Monique T Barakat Mohit Girotra nirav Thosani Shivangi Kothari Subhas Banerjee Divisions of Adult and Pediatric Gastroenterology and Hepatology Stanford University Medical CenterCupertinoCA 95014United States Division of Gastroenterology and Hepatology University of Miami Miller School of MedicineMiamiFL 33136United States Department of Internal Medicine Division of GastroenterologyHepatology&NutritionUniversity of Texas Health Science Center HoustonHoustonTX 77030United States Division of Gastroenterology and Hepatology University of Rochester Medical CenterRochesterNY 14627United States Division of Gastroenterology and Hepatology Stanford University Medical CenterStanfordCA 94304United States

BACKGrOUND At our academic tertiary care medical center, we have noted patients referred for endoscopic retrograde cholangiopancreatography(ErCP) who increasingly require advanced cannulation techniques. This trend is noted despite increased endoscopist experience and annual ErCP volume over the same *** To evaluate this phenomenon of perceived escalation in complexity of cannulation at ErCP and assessed potential underlying *** Demographic/clinical variables and records of ErCP patients at the beginning(2008), middle(2013) and end(2018) of the last decade were reviewed retrospectively. Cannulation approaches were classified as "standard" or "advanced" and duodenoscope position was labeled as "standard"(short position) or "non-standard"(e.g., long, semi-long).rESULTS Patients undergoing ErCP were older in 2018 compared to 2008(69.7 ± 15.2 years vs 55.1 ± 14.7, P reased ampullary distortion and peri-ampullary diverticula were noted in 2018(P rCPs were increasingly performed with a non-standard duodenoscope position, from 2.2%(2008) to 5.6%(2013) and 16.1%(2018)(P re than one advanced cannulation technique for a given ErCP increased from 0.7%(2008) to 0.9%(2013) to 6.6%(2018)(P rimary mass size > 4 cm, pancreatic uncinate mass, and bilirubin > 10 mg/d L predicted use of advanced cannulation techniques(P r each).CONCLUSION Complexity of cannulation at ErCP has sharply increased over the past 5 years, with an increased proportion of elderly patients and those with malignancy requiring advanced cannulation approaches. These data suggest that complexity of cannulation at ErCP may be predicted based on patient/ampulla characteristics. This may inform selection of experienced, high-volume endoscopists to perform these complex procedures.

关键词： Endoscopic retrograde cholangiopancreatography Biliary cannulation Goff trans-pancreatic septotomy Needle knife precut sphincterotomy Endoscopy Complexity

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