Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 8E) docx

... isocratic conditions for deter-mining the most suitable pH for the method. The retention behavior of activeas a function of pH (isocratic) was determined. The best mobile-phase pH for further gradient ... canΠΠrLrLrr23024630460425.....-i.d.column-i.d.column-i.d.column2-i.d.column2==METHOD DEVELOPMENT APPROACHES 425be performed for further structural elucidation of the impurities. Deuteratedexperiments can be performed to support structural assignments.8.5.7 Case ... therefore they can decrease solvent wasteby at least 60%. A simple calculation to achieve equivalent retention on asmaller-i.d. column at the same linear velocity is shown in equation (8-2).For...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 8F) docx

... of analysis is criticalto the success for fast and effective method development. The generalapproach for the method development for the separation of pharmaceutical compounds was discussed, ... SEPARATIONSReversed-phase HPLC is the dominant method used for the majority of pharmaceutical applications (>95%). Normal-phase chromatography may berequired for separations that are not ... R. Vivilecchia, UPLCTM—Acritical look at system/column performance and method transfer considerations for pharmaceutical analytes, HPLC 2005 Conference, Stockholm, Sweden, 2005.41. NIOSH Manual...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 1) docx

... arethree basic types of molecular forces: ionic forces, polar forces, and dispersiveforces. Each speciﬁc technique capitalizes on each of these speciﬁc forces:1. Polar forces are the dominant type ... employedin normal-phase HPLC (see Chapter 5).2. Dispersive forces are employed in reversed-phase HPLC (see Chapter 4).3. Ionic forces are employed in ion-exchange HPLC (see Chapter 4,Section ... OF HPLC 111.7 HPLC DESCRIPTORS (Vr, k, N, etc.)1.7.1 Retention VolumeModern HPLC is a routine tool in any analytical laboratory. Standard HPLC system represents a separation output in the form...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 3) docx

... in HPLC are porous particles with averagediameters between 3 and 10µm. For most pharmaceutical applications, 3-µmparticle sizes are recommended. Porosity provides the surface area necessary for ... predictability of retention and speciﬁcity for theseparation of conformational isomers, and similar advantages are expected for these adsorbents in HPLC. 90 STATIONARY PHASESwhere v is molar ... commercially available HPLC stationary phase is performed by its reaction with alkylchlorosilane-type modiﬁers, reaction (3-9). HCl is generated as a byproduct, and typicallya scavenger for HCl is employed...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 13) docx

... or microorganisms to screen their spectrum of605 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc.65. B. J. Druker, ... formic acid in acetonitrile and A was 0.2% formic acid in water; separation wasperformed at room temperature.importance and a key determinant in obtaining reliable pharmacokinetics(PK) information.A ... alsoapplicable) for semi-automated sample preparation that can accommodateSPE, LLE, and PPT procedures.This scheme has been established for use withSPE, LLE, or PPT in a 96-well plate format to analyze pharmaceutical...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 14) docx

... regulatory HPLC impurity proﬁle, any HPLC method should be validated to some level to ensure acceptable accuracy andprecision.14.9.1 Prevalidation and System SuitabilityPrior to performing a formal ... prior to analysis byreversed-phase LC [21].14.4 HPLC DETECTORSThe detectors utilized for HPLC are designed to respond to the solute beingeluted. HPLC detectors can be classiﬁed into two broad ... solution and (b) a maximum 10–15% RSD for area counts for aminimum of three injections for the LOQ solution.The accuracy of the method can be determined by performing recoveryexperiments or by...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 22) docx

... the two sets of crystals, the molecules are987 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc.which, by substitution ... different afﬁnities for the enantiomers of another substance, thena single enantiomer of the latter will have different afﬁnities for the enan-tiomers of the initial selector. In an effort to design ... have been shown to undergo a conformational change withincreasing temperature. The impact of this conformational change on reten-tion is generally more pronounced for the more retained enantiomer,...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 7A) pptx

... ions on the basis of mass-to-charge ratios,281 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc.150°C, depending ... ﬂow to about 400°C for over 50 µL/min of solvent ﬂow. For LC/APCI-MS, the APCI probe temperature is normally set at 400°C,which can be higher for involatile samples or lower for volatile samples. ... the most widely used systems for analysis of large bio-molecules. For a continuous ion source, the ions can be stored for a shortperiod of time and pulsed out for analysis. In the case of ESI,...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 7B) pptx

... metabolites areimportant biotransformation pathways for many drugs and xenobiotics [127,132, 133]. For example, the formation of acyl glucuronide conjugate forced thewithdrawal of four marketed ... intermediates for formation of the keto acid, were also observed in the radiochromatogramof rat plasma (spectrum not shown) [131].PRACTICAL APPLICATIONS 335Scheme 11. Mechanism for the formation ... driving force for the fragmentationof an ion is dependent on the stabilities of the resulting ion and the radicalspecies relative to the energy of the initial ionic species. For instance, the for- mation...

Tài liệu HPLC for Pharmaceutical Scientists 2007 (Part 8A) ppt

... the ACD prediction of the solubil-ity for the ionized form of bases and acids shows greater deviation than for the solubility predicted for the neutral form of the molecules.Reaction of the ... during method development; these include speed347 HPLC for Pharmaceutical Scientists, Edited by Yuri Kazakevich and Rosario LoBruttoCopyright © 2007 by John Wiley & Sons, Inc. ... different solutions prepared at the different pHvalues. For example, in Figure 8-7 if the target concentration for the HPLC assay is 1 mg/mL for this basic compound, then the sample at pH 1 (8 mg/mL356...

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