Abstract
Method validation is a necessary exercise in which the method under assessment is proven to be “fit for purpose”. The experiments follow a predetermined protocol and the results must meet predetermined criteria of performance. The exact experiments conducted are dependent on the type of testing being undertaken and the extent of the method’s usage. Table 11.1 gives some examples of validation studies in CE, detailing the validation aspects studied in the individual studies (1–20). Each of these validation aspects are then discussed in this chapter.
Keywords
- Capillary Electrophoresis
- Migration Time
- Drug Substance
- Losartan Potassium
- Capillary Electrophoresis Method
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Castaneda G Penalvo E J, and Fabre H, Cross validation of capillary electrophoresis and high-performance liquid chromatography for cefotaxime and related impurities, Chromatographia, 42 (1996) 159–164.
Kelly M A, Altria K D, Grace C, and Clark B J, Optimisation, validation and application of a capillary electrophoresis method for the determination of ranitidinehydrochloride and related substances, J. Chromatogr. A, in press 1998.
Shah PA and Quinones L, Validation of a micellar electrokinetic capillary chromatography (MECC) method for the determination of p-toluenesulfonic acid impurity in a pharmaceutical intermediate, J. Liq. Chromatogr., 18 (1995) 1349–1362.
Bullock J, Capillary Electrophoresis purity method for the novel metal chelator TMT-NCS, J. Pharm. Biomed. Anal., 14 (1996) 845–854.
Shaafati A and Clark B J, Development and validation of a capillary zone electrophoretic method for the determination of atenolol in presence of its related substances in bulk and tablet dosage form, J. Pharm. Biomed. Anal., 14 (1996) 1547–1554.
Altria K D, Bryant S M, and Hadgett T, Validated capillary electrophoresis method for the assay of a range of acidic drugs and excipients, J. Pharm. Biomed. Anal., 15 (1997) 1091–1101.
Wynia G S, Windhorst G, Post P C, and Maris F A, Development and validation of a capillary electrophoresis method within a pharmaceutical quality control environment and comparison with high-performance liquid chromatography, J. Chromatogr. A, 773 (1997) 339–350.
Thomas B R, Fang X G, Chen X, Tyrell R J, and Ghodbane S, Validated micellar electrokinetic capillary chromatography method for the quality control of the drug substances hydrochlorothiazide and chlorothiazide, J. Chromatogr., 657 (1994) 383–394.
Bechet I, Fillet M, Hubert Ph, and Crommen J, Quantitative analysis of non-steroidal anti-inflammatory drugs by capillary zone electrophoresis, J. Pharm. Biomed. Anal., 13 (1995) 497–503.
Williams R C, Alasandro M S, Fasone V L, Boucher R J, and Edwards J F, Comparison of liquid chromatography, capillary electrophoresis and super-critical fluid chromatography in the determination of Losartan Potassium drug substance in Cozaar tablets, J. Pharm. Biomed. Anal., 14 (1996) 1539–1546.
Altria KD, Frake P, Gill I, Hadgett T, Kelly MA, and Rudd D R, Validated capillary electrophoresis method for the assay of a range of basic drugs and excipients, J. Pharm. Biomed. Anal., 13 (1995) 951–957.
Sanger-van de Griend C E, Wahlstrom H, Groningsson K, and Widahl-Nasman M, A chiral capillary electrophoresis method for ropivacaine hydrochloride in pharmaceutical formulations: validation and comparison with chiral liquid chromatography, J. Pharm. Biomed. Anal., 15 (1997) 1051–1061.
Liu L, Osborne LM, and Nussbaum MA, Development and validation of a combined assay and enantiomeric purity for a chiral pharmaceutical compound using capillary electrophoresis, J. Chromatogr. A, 745 (1996) 45–52.
Noroski J E, Mayo D J, and Moran M, Determination of the enantiomer of a cholesterol-lowering drug by cyclodextrin-modified micellar electrokinetic chromatography, J. Pharm. Biomed. Anal., 13 (1995) 54–52.
Altria K D, Harkin P, and Hindson M, Validation of a CE method for the quantitative determination of trytophan enantiomers, J. Chromatogr. B, 686 (1996) 103–110.
Altria K D, Assi K, Bryant S, and Clarke B J, Quantitative analysis of organic acid drug counterions by capillary electrophoresis, Chromatographia, 44 (1997) 367–371.
Zhou L and Dovletoglou A, Practical capillary electrophoresis method for the quantitation of the acetate counter-ion, J. Chromatogr. A, 763 (1997) 279–284.
Altria K D, Wood T, Kitscha R, and Roberts-Mcintosh A, Validation of a capillary electrophoresis method for the determination of potassium counter-ion levels in an acidic drug salt, J. Pharm. Biomed. Analysis, 13 (1995) 33–38.
Coors C, Schulz H-G, and Stache F, Development and validation of bioanalytical method for the quantitation of diltiazem and desacetyldiltiazem in plasma by capillary zone electrophoresis, J. Chromatogr. A, 717 (1995) 235–243.
Sandor V, Flarakos T, Batist G, Wainer I W, and Lloyd D K, Quantitation of the diastereoisomers of l-buthionine-(r,s)-sulfoximine in human plasma: A validated assay by capillary electrophoresis, J. Chromatogr. B, 673 (1995) 123–131.
Altria K D and Rudd D R, An overview of method validation and system suitability aspects in capillary electrophoresis, Chromatographia, 41 (1995) 325–331.
Watzig H, Appropriate calibration functions for capillary electrophoresis. 1. Precision and sensitivity using peak areas and heights, J. Chromatogr. A, 700 (1995) 1–7.
Altria K D, Walsh A R, and Smith N W, Validation of a capillary electrophoresis method for the enantiomeric purity testing of fluparoxan, J. Chromatogr., 645 (1993) 193–196.
Altria K D, Essential peak area normalisation in Capillary Electrophoresis, Chromatographia, 35 (1993) 177–182.
Kelly M A, Altria KD, and Clark B J, Approaches used in the reduction of buffer electrolysis effects in routine capillary electrophoresis procedures, J. Chromatogr. A, 768 (1997) 73–80.
Altria K D and Dave K, Peak homogeniety determination and micro-preparative fraction collection by capillary electrophoresis in pharmaceutical analysis, J. Chromatogr., 633 (1993) 221–225.
Altria K D, Harden R C, Hart M, Hevizi J, Hailey P A, Makwana J, and Portsmouth M J, An intercompany cross-validation exercise on capillary electrophoresis. 1. Chiral analysis of clenbuterol, J. Chromatogr., 641 (1993) 147–153.
Altria K D, Clayton N G, Harden R C, Hart M, Hevizi J, Makwana J, and Portsmouth M J, An inter-company cross-validation exercise on capillary electrophoresis testing of dose uniformity of paracetamol content in formulations, Chromatographia, 39 (1994) 180–184.
Altria K D, Clayton N G, Harden R C, Hart M, Hevizi J, Makwana J, and Portsmouth M J, Inter-company cross-validation exercise on capillary electrophoresis. Quantitative determination of drug counter-ion level, Chromato graphia, 40 (1995) 47–50.
Guttman A and Cooke N, Practical aspects in chiral separation of pharmaceuticals by capillary electrophoresis. 2. Quantitative separation of naproxen enantiomers J. Chromatogr. A, 685 (1994) 155–159.
Wynia G S, Windhorst G, Post P C, and Mars F A, Development and validation of a capillary electrophoresis method within a pharmaceutical quality control environment and comparison with high-performance liquid chromatography, J. Chromatogr. A, 773 (1997) 339–350.
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 1998 Friedr. Vieweg & Sohn Verlagsgesellschaft mbH, Braunschweig/Wiesbaden
About this chapter
Cite this chapter
Altria, K.D. (1998). Method Validation. In: Analysis of Pharmaceuticals by Capillary Electrophoresis. Chromatographia CE Series, vol 2. Vieweg+Teubner Verlag. https://doi.org/10.1007/978-3-322-85011-9_11
Download citation
DOI: https://doi.org/10.1007/978-3-322-85011-9_11
Publisher Name: Vieweg+Teubner Verlag
Print ISBN: 978-3-322-85013-3
Online ISBN: 978-3-322-85011-9
eBook Packages: Springer Book Archive