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HPLC stability-indicating method

A selective, sensitive and stability indicating reversed phase-HPLC method was developed for the determination of clarithromycin antibiotic in human plasma. [Pg.395]

A stability-indicating HPLC method has been described for niclosamide in artificial gastric and intestinal juices [68],... [Pg.88]

Since its creation around 1973, modern high-pressure liquid chromatography (HPLC) has played a dominant role in the analysis of pharmaceuticals. It is used in many different applications for example, in content uniformity assays and stability-indicating methods, for the purity profiles of drug substances, or in the analysis of drug metabolism in animals and humans. The heart of all of these assays is the HPLC column. In this chapter, we will describe the fundamental properties of HPLC columns as well as how these properties influence column performance and separation characteristics in pharmaceutical assays. [Pg.78]

To develop an HPLC stability-indicating method for Type I or II dissolution, the linearity must be wide enough, in combination with good sensitivity and minimal interference, to accommodate concentrations from low (possibly LOQ) to very high end, as the samples drawn represent the cumulative drug amount dissolved over time. As for an FiPLC method that is designed for Type VII dissolution, the linearity should accommodate the lower concentrations since it is a drug measurement of a controlled-release system. [Pg.352]

Even if HPLC is chosen as the main stability indicating method, CE will be useful as orthogonal technique, especially in cases where the reason of mass balance deviations is unclear. In addition, due to its increased peak capacity and selectivity in comparison to HPLC, the detection of possible enantiomers, stereoisomers, and position isomers, having the same molecular weight and equal/similar spectra as the drug substance may be separated by a secondary CE method. [Pg.113]

Functional Requirements. Based on the user requirements, more detailed functional requirements can then be defined. Take as an example a gradient HPLC system with UV-Vis detection required to run a stability-indicating method. The functions of each of the hardware and software components required to perform the tasks in the user requirements should be specified. The functional specifications typically include ... [Pg.143]

Ruan, J., Tattersall, P, Lozano, R., and Shah, P. (2006). The role of forced degradation studies in stability indicating HPLC method developmerWm. Pharm. Rev., 9, 463. [Pg.89]

G.B. Chaudhari, N. Patel, P.B. Shah, Stability indicating RP-HPLC method for simultaneous determination of atorvastatin and amlodipine from their combination drug products, Chem. Pharm. Bull. 55 (2007) 241-246. [Pg.69]

FDA-483 issued for API. In the HPLC gradient procedure, used also as the firm s stability-indicating method, the firm lacks data that demonstrate the suitability of a resolution requirement of 3.0 between X and Y to establish the suitability of the chromatographic system. [Pg.182]

T. Kubala, B. Gamblhir, and J. I. Borst, A specific stability indicating HPLC method to determine diclofenac in raw materials and pharmaceutical solid dosage forms, Drug Dev. Ind. Pharm, 19 749(1993). [Pg.234]

G. Parhizkani, R. B. Miller, and C. Chen, A stability-indicating HPLC method for the determination of benzalkonium chloride in phenylephrine HG 10% ophthalmic solution, J. Liquid Chromatogr., 78 553 (1995). [Pg.407]

K. Shivram, A. C. Shah, B. L. Newalhar, and B. V. Kamath, Stability indicating HPLC method for the assay of diltiazem hydrochloride in tablets, J. Liquid Chromatogr., 75 2417 (1992). [Pg.414]

A stability indicating HPLC method has been developed to measure etodolac in presence of three main degradants, 7-ethyl-2-( 1 -methylene-propyl)- 1 -//-indole-3 -ethanol, the decarboxylated product of etodolac, and 7-ethyltryptophol [23]. A reverse phase ODS column (15 cm x 0.41 cm i.d., 5 pm particles) was used to achieve separation. The mobile phase... [Pg.132]

Tao et al. described an HPLC method for the determination of acetylcholine in a pharmaceutical preparation [145]. Utilizing reverse phase ion pairing, acetylcholine was determined in lyophilized ophthalmic preparations. Analysis of degraded commercial samples showed the utility of the method in quantitation, being stability indicating, and useful in separating acetylcholine from choline. [Pg.79]

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See also in sourсe #XX -- [ Pg.597 ]



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HPLC methods

HPLC stability-indicating method approach

HPLC stability-indicating method development

HPLC stability-indicating method drugs

HPLC stability-indicating method process

Indicator methods

Stability methods

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