Development and validation of indirect RP-HPLC method for enantiomeric purity determination of d-cycloserine drug substance

Journal of Pharmaceutical and Biomedical Analysis

Volumn 54, Issue 4, 2011, Pages 850-854

  Karthikeyan, K ^a,b   Arularasu, G T ^a   Ramadhas, R ^a   Pillai, K Chandrasekara ^b  

^a Shasun Research Center   (India)

^b UNIVERSITY OF MADRAS   (India)

Author keywords

Chiral purity; Cycloserine; Derivatization; RP HPLC; UV detection

Indexed keywords

ACETYLCYSTEINE; CYCLOSERINE; DISODIUM HYDROGEN PHOSPHATE; PHTHALALDEHYDE;

ACIDITY; ALKALINITY; ARTICLE; CHIRALITY; CONTROLLED STUDY; DERIVATIZATION; DIASTEREOISOMER; DRUG DETERMINATION; DRUG PURITY; DRUG STABILITY; ELUTION; ENANTIOMER; FLOW RATE; HUMIDITY; LIGHT; OXIDATION; PH; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SENSITIVITY AND SPECIFICITY; THERMODYNAMICS; ULTRAVIOLET RADIATION; VALIDATION STUDY;

ACETYLCYSTEINE; ANALYTIC SAMPLE PREPARATION METHODS; ANTIBIOTICS, ANTITUBERCULAR; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CYCLOSERINE; DRUG CONTAMINATION; DRUG STABILITY; HYDROGEN-ION CONCENTRATION; INDICATORS AND REAGENTS; ISOMERISM; LIMIT OF DETECTION; MICROCHEMISTRY; O-PHTHALALDEHYDE; QUALITY CONTROL; REPRODUCIBILITY OF RESULTS; TECHNOLOGY, PHARMACEUTICAL;

EID: 78650233216     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2010.10.015     Document Type: Article

References (21)

1. The Merck Index 2006, Merck & Co., Inc., USA, pp. 461-461. 14th ed.
2. David S. Synergic activity of d-cycloserine and β-chloro-d-alanine against Mycobacterium tuberculosis. J. Antimicrob. Chemother. 2001, 47:203-206.
3. US Pharmacopeial Convention, USP32 NF27, 2009, p. 2043.
4. WHO The International Pharmacopoeia 2008, WHO, Geneva.
5. Tanaka Y., Otsuka K., Terabe S. Separation of enantiomers by capillary electrophoresis-mass spectrometry employing a partial filling technique with a chiral crown ether. J. Chromatogr. A 2000, 875:323-330.
6. ICH Impurities in New Drug Substances, Q3A [R2], Step 5 2006.
7. U.S.FDA Impurities in Drug Substances 2000.
8. EMEA Impurities in New Drug Substances, CPMP/ICH/2737/99 2006.
9. Snyder L.R., Kirkland J.J., Glajch J.L. Practical HPLC Method Development 1997, John Wiley & Sons, New York, pp. 539-540. 2nd ed.
10. Ahuja S. Chiral Separations-Applications and Technology 1997, ACS, Washington, pp. 142-143.
11. Ilisz I., Berkecz R., Peter A. Application of chiral derivatizing agents in the high-performance liquid chromatographic separation of amino acid enantiomers: a review. J. Pharm. Biomed. Anal. 2008, 47:1-15.
12. Subramanian G. Chiral Separation Techniques-A Practical Approach 2001, Wiley, VCH, NY, pp. 188-192.
13. Bruckner H., Gah C. High-performance liquid chromatographic separation of dl-amino acids derivatized with chiral variants of Sanger's reagent. J. Chromatogr. 1991, A555:81-95.
14. Bhushan R., Kumar V. Indirect resolution of baclofen enantiomers from pharmaceutical dosage form by reverse phase liquid chromatography after derivatization with Marfey's reagent and its structural variants. Biomed. Chromatogr. 2008, 22:906-911.
15. Nimura N., Kinoshita T. o-Phthalaldehyde-N-acetyl-l-cysteine as a chiral derivatization reagent for liquid chromatographic optical resolution of amino acid enantiomers and its application to conventional amino acid analysis. J. Chromatogr. 1986, A352:169-177.
16. Garcia Alvarez-Coque M.C., Medina Hernandez M.J., Villanueva Camanas R.M., Mongay Fernandez C. Formation and instability of o-phthalaldehyde derivatives of amino acids. Anal. Biochem. 1989, 178:1-7.
17. Garcia Alvarez-Coque M.C., Medina Hernandez M.J., Villanueva Camanas R.M., Mongay Fernandez C. Studies on the formation and stability of isoindoles derived from amino acids, o-phthalaldehyde and N-acetyl-l-cysteine. Anal. Biochem. 1989, 180:172-176.
18. ICH Validation of Analytical Procedures, Q2 (R1), Step 5 2005.
19. US Pharmacopeial Convention, USP32 NF27, 2009, pp. 733-736.
20. Analytical Profiles of Drug Substances 1972, vol. 1:53-64. Academic Press, NY.
21. Krull I., Swartz M. Determining specificity in a regulated environment. LC-GC 2001, 19:604-614.