Cleaning validation 1: development and validation of a chromatographic method for the detection of traces of LpHse detergent.

Abstract:

:A high performance liquid chromatography (HPLC) method for the detection of traces of LpHse (4-tert-amylphenol and 2-phenylphenol) has been developed and validated. The method was shown to be linear in the range from 0.5 to 10.00 ppm in solution. The method was also shown to be accurate with a recovery of up to 95% by area response for amylphenol and up to 94% by area response for phenylphenol from metal surfaces (4''x4'' un-polished 304 stainless steel plates) by means of swab material. The reproducibility of the method was determined to be 1.61% by area response and 1.52% by height response for amylphenol and 5.40% by area response and 13.77% by height response for phenylphenol from solutions reported as the pooled relative standard deviation. The developed method was also shown to be rugged by comparisons of different preparations by different analysts. The limit of detection was established to be 0.076 ppm by peak area, 0.079 ppm by peak height for amylphenol and 0.34 ppm by peak area, 0.82 ppm by peak height for phenylphenol from solution, and 1.77 ppb by peak area, 1.23 ppm by peak height for amylphenol and 1.23 ppm by peak area, 1.44 ppm by peak height for phenylphenol from recovery from metal studies. The limit of quantitation was established to be 0.25 ppm by peak area, 0.26 ppm by peak height for amylphenol and 1.14 ppm by peak area, 2.73 ppm by peak height for phenylphenol from solution, and 3.89 ppm by peak area, 4.11 ppm by peak height for amylphenol and 4.11 ppm by peak area, 4.79 ppm by peak height for phenylphenol from recovery from metal plates studies. This method can be employed to determine the presence of LpHse residues in cleaned equipments where the detergent was used.

journal_name

J Pharm Biomed Anal

authors

Zayas J,Colón H,Garced O,Ramos LM

doi

10.1016/j.jpba.2005.10.049

subject

Has Abstract

pub_date

2006-05-03 00:00:00

pages

589-93

issue

2

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(05)00723-5

journal_volume

41

pub_type

杂志文章
  • Liquid chromatography assay for amlodipine: chemical stability and pharmacokinetics in rabbits.

    abstract::Amlodipine is a long acting dihydropyridine calcium antagonist recently introduced for the treatment of angina and hypertension. In order to document its stability in vitro and to develop a pharmacokinetic model in rabbits, a new reversed-phase liquid chromatography (LC) assay with UV detection was developed. The meth...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(91)80178-c

    authors: Yeung PK,Mosher SJ,Pollak PT

    更新日期:1991-01-01 00:00:00

  • Biotransformation and in vitro assessment of metabolism-associated drug-drug interaction for CRx-102, a novel combination drug candidate.

    abstract::CRx-102 is an oral synergistic combination drug which contains the cardiovascular agent, dipyridamole (DP) and a very low dose of the glucocorticoid, prednisolone (PRED). CRx-102 works through a novel mechanism of action in which DP selectively amplifies the anti-inflammatory activity of PRED without replicating its s...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2009.04.013

    authors: Zhang ZY,Chen M,Chen J,Padval MV,Kansra VV

    更新日期:2009-09-08 00:00:00

  • Design and international harmonization of pharmacopoeial standards.

    abstract::As the global market for pharmaceuticals increases, the adverse consequences of different regulations and requirements are becoming more obvious. Discussions between the regulatory authorities for the European Community, United States and Japan under the International Conference on Harmonization (ICH) intended to remo...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(95)01578-7

    authors: Calam DH

    更新日期:1995-12-01 00:00:00

  • Simple and rapid simultaneous profiling of minor components of honey by size exclusion chromatography (SEC) coupled to ultraviolet diode array detection (UV-DAD), combined with chemometric methods.

    abstract::This paper discusses the importance of profiling UV-responsive components, properly integrated with chemometric techniques, in detecting indicative parameters for quality control of honey. The minor components in honeys of different botanical and geographical origins were investigated by size SEC-UV-DAD. We diluted ho...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2011.09.006

    authors: Beretta G,Fermo P,Maffei Facino R

    更新日期:2012-01-25 00:00:00

  • Development of simple isocratic HPLC methods for siRNA quantitation in lipid-based nanoparticles.

    abstract::This paper describes the development of simple and user-friendly HPLC methods that can quantitate the amount of small interfering RNA (siRNA) in lipid-based nanoparticle (LNP) formulations. The methods have been used as alternative chromatographic approaches to the size exclusion chromatography in order to perform "fi...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2019.04.026

    authors: Huang Z,Fish WP

    更新日期:2019-08-05 00:00:00

  • A New titania glyco-purification tip for the fast enrichment and efficient analysis of glycopeptides and glycans by MALDI-TOF-MS.

    abstract::Enrichment and/or purification of intact glycopeptides and derivatized glycans are essential for mass spectrometry-based glycoproteomics and glycomics because of analytical challenges observed in the analysis. Here, a titania-based material was synthesized using a facile sol-gel method for the efficient analysis of gl...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2019.05.061

    authors: Hacı Mehmet K,İzzet A,Bekir S

    更新日期:2019-09-10 00:00:00

  • Quantitation of the anticancer drug abiraterone and its metabolite Δ(4)-abiraterone in human plasma using high-resolution mass spectrometry.

    abstract::Abiraterone acetate is administered as a prodrug to patients with metastatic, castration-resistant prostate cancer (mCRPC) and is readily metabolized into the potent 17a-hydroxylase/17,20-lyase (CYP17) enzyme inhibitor and androgen receptor inhibitor abiraterone and Δ(4)-abiraterone (D4A), respectively. To investigate...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2018.03.012

    authors: Bhatnagar A,McKay MJ,Crumbaker M,Ahire K,Karuso P,Gurney H,Molloy MP

    更新日期:2018-05-30 00:00:00

  • Improved capillary electrophoresis method for the analysis of carbohydrate-deficient transferrin in human serum, avoiding interference by complement C3.

    abstract::Capillary electrophoresis (CE) methods for transferrin analysis are widely used in clinical laboratories, but complement C3 peaks often overlap with carbohydrate-deficient transferrin peaks. In this study, we discovered that the electrophoretic mobility of the complement C3 peak could be controlled by adding carboxyme...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2012.12.011

    authors: Kuroda Y,Hamaguchi R,Moriyama K,Tanimoto T,Haginaka J

    更新日期:2013-03-25 00:00:00

  • An ion exchange liquid chromatography/mass spectrometry method for the determination of reduced and oxidized glutathione and glutathione conjugates in hepatocytes.

    abstract::A rugged LC-MS/MS method was developed to quantify reduced and oxidized glutathione (GSH and GSSG, respectively) in rat hepatocytes. In addition, GSH conjugates can be detected, characterized and measured in the same analysis. Samples were treated with acetonitrile and iodoacetic acid to precipitate proteins and trap ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(01)00402-2

    authors: Loughlin AF,Skiles GL,Alberts DW,Schaefer WH

    更新日期:2001-08-01 00:00:00

  • Comparison between mono- and bi-exponential models for reaction kinetics in the immunoradiometric assay of neuron-specific enolase.

    abstract::This paper studies the kinetics of the antigen-antibody reactions involved in the analytical determination of neuron-specific enolase (NSE) by means of radiometric immunoassay (IRMA). For the global process, kinetics were found to be dependent on analyte and labelled antibody concentrations, such dependence fitting wi...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(03)00418-7

    authors: García Gómez J,Moreno Frigols JL

    更新日期:2003-12-04 00:00:00

  • Glutathione S-transferase pi trapping method for generation and characterization of drug-protein adducts in human liver microsomes using liquid chromatography-tandem mass spectrometry.

    abstract::Covalent binding of reactive metabolites (RMs) to proteins is thought to play an important role in the processes leading to adverse drug reactions. Therefore, there is great interest in methodologies that enable the characterization of covalent binding of drugs to proteins. To facilitate the study of drug-protein addu...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2012.04.035

    authors: Yukinaga H,Iwabuchi H,Okazaki O,Izumi T

    更新日期:2012-08-01 00:00:00

  • Investigation on Raman spectral features of a coated tablet under variation of its orientation respective to laser illumination and measurement of nominal coating thickness of packed tablets.

    abstract::To investigate Raman spectral features of a coated biconvex tablet under variation of its orientation respective to laser illumination, spectra of the tablet were collected by illuminating laser on 12 different locations on the tablet with 3 different illumination angles of 45, 75 and 90°. The spectral variations were...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2016.08.038

    authors: Kim J,Hwang J,Woo YA,Chung H

    更新日期:2016-11-30 00:00:00

  • Dibekacin assay in serum by automated fluorescence polarization immunoassay (Abbott Tdx): comparison with high-performance liquid chromatography, substrate-labelled fluorescent immunoassay and radioimmunoassay.

    abstract::An immunoassay based on fluorescence polarization detection (FPIA) has been recently adapted for dibekacin. This has been compared with a reference method (high-performance liquid chromatography), and two other methods used in clinical laboratories for monitoring this aminoglycoside, namely substrate-labelled fluoresc...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(86)80023-1

    authors: Rollman B,Van der Auwera P,Tulkens PM

    更新日期:1986-01-01 00:00:00

  • A spectroscopic investigation of DuP 747 polymorphs.

    abstract::DuP 747, a selective kappa agonist analgesic, was found to have at least two polymorphic forms, and this was confirmed by X-ray powder diffraction. DSC and thermomicroscopic studies indicated the polymorphic pair to be monotropic. Solubility studies suggested the relative stability of the two forms to be similar. The ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(94)e0002-i

    authors: Raghavan K,Dwivedi A,Campbell GC Jr,Nemeth G,Hussain MA

    更新日期:1994-06-01 00:00:00

  • A sensitive HPLC-UV method for quantifying vancomycin in biological matrices: Application to pharmacokinetic and biodistribution studies in rat plasma, skin and lymph nodes.

    abstract::Vancomycin (VCN) is an antibiotic used in the treatment of methicillin-resistant Staphylococcus aureus (MRSA)-derived infections. As it has a relatively narrow therapeutic window, it is imperative to develop a sensitive and reliable analytical method for drug monitoring and pharmacokinetic purposes. In the present stu...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113429

    authors: Ramadon D,Courtenay AJ,Permana AD,Tekko IA,McAlister E,McCrudden MTC,McCarthy HO,Donnelly RF

    更新日期:2020-09-10 00:00:00

  • SPE-HPLC method for the determination and pharmacokinetic studies on paeoniflorin in rat serum after oral administration of traditional Chinese medicinal preparation Guan-Xin-Er-Hao decoction.

    abstract::A new HPLC method for the determination of paeoniflorin in rat serum with solid-phase extraction (SPE) for preconcentration is introduced. Paeoniflorin and an internal standard (pentoxifylline) were extracted from serum by means of SPE using cartridges with octadecyl chemically bound phase. The HPLC separation was the...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(03)00294-2

    authors: Ye G,Li YZ,Li YY,Guo HZ,Guo DA

    更新日期:2003-10-15 00:00:00

  • The physicochemical properties of oestradiol.

    abstract::The spectral, solubility and related physicochemical characteristics of the ovarian hormone are presented. A review of its crystal properties indicates that the common crystalline form of the steroid is the hemihydrate. ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(87)80076-6

    authors: Salole EG

    更新日期:1987-01-01 00:00:00

  • Chemical profiling and quantitation of bioactive compounds in Platycladi Cacumen by UPLC-Q-TOF-MS/MS and UPLC-DAD.

    abstract::Platycladi Cacumen (PC) is a traditional Chinese medicine used for the treatment of hemorrhages, cough, asthma and hair loss. To get a better understanding of the chemical constituents in PC, ultra-high performance liquid chromatography coupled with electrospray ionization quadrupole time-of-flight tandem mass spectro...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2018.03.005

    authors: Zhuang B,Bi ZM,Wang ZY,Duan L,Lai CJ,Liu EH

    更新日期:2018-05-30 00:00:00

  • 600 MHz 1H-NMR spectroscopy of human cerebrospinal fluid: effects of sample manipulation and assignment of resonances.

    abstract::Extensive assignments of resonances in the 600 MHz 1H-NMR spectra of cerebrospinal fluid are reported. These have been achieved by the measurement of a combination of two-dimensional experiments comprising homonuclear J-resolved, COSY45, and double-quantum filtered COSY (DQCOSY) spectra. By these means the previous to...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(93)80171-v

    authors: Sweatman BC,Farrant RD,Holmes E,Ghauri FY,Nicholson JK,Lindon JC

    更新日期:1993-08-01 00:00:00

  • Rapid UPLC-MS/MS method for the determination of ketoprofen in human dermal microdialysis samples.

    abstract::Dermal microdialysis (DMD) is a technique capable of determining the percutaneous penetration of drugs from topical formulations intended for local and/or regional activity. Typically, the concentrations of drug collected in dialysates are very low, generally in the ng/ml or even pg/ml range. An additional challenge i...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2008.09.051

    authors: Tettey-Amlalo RN,Kanfer I

    更新日期:2009-11-01 00:00:00

  • Characterization of eptifibatide during drug formulation stability assays.

    abstract::The objective of the study was to determine the identity of a new impurity detected in HPLC chromatograms of research samples of eptifibatide manufactured by a new process and formulated into drug product. The identification of the unknown impurity was required in order to understand the mechanism of its formation. Th...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(03)00409-6

    authors: Wang R,Feder D,Hsieh F

    更新日期:2003-12-04 00:00:00

  • Time-resolved fluoroimmunoassay for pituitary adenylate cyclase activating polypeptide 27 (PACAP27) using europium (III) ion chelate labeled streptavidin-biotin complex.

    abstract::Pituitary adenylate cyclase activating polypeptide (PACAP) is a novel peptide hormone and has a variety of biological action. In studies of the physiological behaviour of endogenous PACAP, the determination of PACAP levels in biological materials require a highly sensitive and specific method. Therefore, we developed ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(96)01985-1

    authors: Ito K,Goto T,Tsuji A,Maeda M

    更新日期:1997-06-01 00:00:00

  • LC, LC-MS/TOF and MS(n) studies for the identification and characterization of degradation products of nelfinavir mesylate.

    abstract::The objective of the present investigation was to separate, identify and characterize the major degradation products (DPs) of nelfinavir mesylate generated under hydrolytic, oxidative, photolytic and thermal stress conditions as advised in International Conference on Harmonization (ICH) guideline Q1A(R2). The drug was...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2011.02.020

    authors: Tiwari RN,Bonde CG

    更新日期:2011-06-01 00:00:00

  • Polymeric matrix membrane sensors for sensitive potentiometric determination of some beta-blockers in pharmaceutical preparations.

    abstract::Five poly(vinyl chloride) matrix membrane sensors responsive to some beta-blockers (atenolol, bisoprolol, metoprolol, propranolol and timolol) are described and characterized. The sensors are based on the use of the ion-association complexes of the beta-blocker cations with tungstophosphate anion as electroactive mate...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(03)00015-3

    authors: Hassan SS,Abou-Sekkina MM,El-Ries MA,Wassel A

    更新日期:2003-04-24 00:00:00

  • Development and validation of a sensitive liquid chromatography/electrospray tandem mass spectrometry assay for the quantification of olanzapine in human plasma.

    abstract::A simple, sensitive and rapid liquid chromatography/electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) method was developed and validated for the quantification of olanzapine, atypical antipsychotic drug, in human plasma using loratadine as internal standard (IS). Following liquid-liquid extraction, the a...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2006.01.040

    authors: Nirogi RV,Kandikere VN,Shukla M,Mudigonda K,Maurya S,Boosi R,Yerramilli A

    更新日期:2006-06-07 00:00:00

  • High-performance liquid chromatographic mapping of the oligosaccharides released from the humanised immunoglobulin, CAMPATH 1H.

    abstract::A sensitive and reproducible method for the routine mapping of oligosaccharides in a humanised immunoglobulin (IgG) is described. The method involves the enzymic release of intact glycans using the endoglycosidase glycopeptidase-F, and subsequent derivatisation with 1-phenyl-3-methyl-5-pyrazolone to facilitate analysi...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/0731-7085(95)01646-5

    authors: Lines AC

    更新日期:1996-03-01 00:00:00

  • Rapid and sensitive determination of four bisphosphonates in rat plasma after MTBSTFA derivatization using liquid chromatography-mass spectrometry.

    abstract::Bisphosphonates (BPs) have broad medical applications against osteoporosis, bone metastasis and Paget's disease. The BP-related jaw osteonecrosis limits their use extensively and has a causal relationship with the process of drug disposition, such as deposition on bone and slow elimination rate. Thus it is imperative ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2020.113579

    authors: Zhang HX,Li Y,Li Z,Lam CWK,Chen HW,Luo WD,Wang CY,Jiang ZH,Du ZY,Zhang W

    更新日期:2020-10-25 00:00:00

  • Quality control of pharmaceutical formulations containing cisplatin, carboplatin, and oxaliplatin by micellar and microemulsion electrokinetic chromatography (MEKC, MEEKC).

    abstract::A micellar electrokinetic chromatography (MEKC) method was developed for the determination of cisplatin, carboplatin, and oxaliplatin in pharmaceutical formulations. The background electrolyte consisted of a phosphate buffer (pH 7.0; 25 mM) with sodium dodecyl sulfate (80 mM). The applied voltage was 30 kV and the sam...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2011.01.029

    authors: Nussbaumer S,Fleury-Souverain S,Schappler J,Rudaz S,Veuthey JL,Bonnabry P

    更新日期:2011-05-15 00:00:00

  • LC and LC-MS study of stress decomposition behaviour of isoniazid and establishment of validated stability-indicating assay method.

    abstract::Isoniazid was subjected to different ICH prescribed stress conditions of thermal stress, hydrolysis, oxidation and photolysis. The drug was stable to dry heat (50 and 60 degrees C). It showed extensive decomposition under hydrolytic conditions, while it was only moderately sensitive to oxidation stress. The solid drug...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/j.jpba.2006.10.013

    authors: Bhutani H,Singh S,Vir S,Bhutani KK,Kumar R,Chakraborti AK,Jindal KC

    更新日期:2007-03-12 00:00:00

  • Simultaneous HPLC determination of multiple components in a commercial cosmetic cream.

    abstract::A high-performance liquid chromatographic method for the simultaneous determination of magnesium ascorbyl phosphate (I), imidazolidinylurea (II), a mixture of methyl-(III), ethyl-(IV), propyl-(V), butyl-(VI) parabens dissolved in phenoxyethanol, and ascorbyl palmitate (VII), was studied by using a cyano-propyl column ...

    journal_title:Journal of pharmaceutical and biomedical analysis

    pub_type: 杂志文章

    doi:10.1016/s0731-7085(98)00173-3

    authors: Sottofattori E,Anzaldi M,Balbi A,Tonello G

    更新日期:1998-10-01 00:00:00