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An improved and validated LC method for resolution of bicalutamide enantiomers using amylose tris-(3,5-dimethylphenylcarbamate) as a chiral stationary phase.
J Pharm Biomed Anal. 2006 Sep 26; 42(3):347-53.JP

Abstract

An improved HPLC method for determination of enantiomeric purity of bicalutamide in drugs and pharmaceuticals was developed and validated. Baseline separation with resolution >/=6.0 was achieved within 10 min on Chiralpak AD-H (250 mm x 4.6 mm; particle size 5 microm) column using n-hexane:2-propanol (65:35 v/v) as mobile phase at a flow rate of 1.0 ml/min at 25 degrees C. The detection was made at 270 nm using UV detector while a polarimetric detector connected in series was used for identification of enantiomers. The effects of 2-propanol, ethanol and temperature on enantioselectivity and resolution of enantiomers were evaluated. The method was validated in terms of accuracy, precision and linearity in the range of 10-250 microg/ml and the r(2) was >0.9999. The recoveries were 99.68-100.25% with <1% R.S.D. The limits of detection (LOD) and quantification (LOQ) of enantiomers were (2.4, 3.0 and 7.6, 9.3) x 10(-8)g/ml for (S)-(+)-BCT and (R)-(-)-BCT enantiomers, respectively. The method was found to be suitable for rapid determination of enantiomeric purity of bicalutamide in bulk drugs and pharmaceutical formulations.

Authors+Show Affiliations

HPLC/UV Group, Analytical Chemistry Division, Discovery Laboratory, Indian Institute of Chemical Technology, Hyderabad 500007, India. mnrao@iictnet.orgNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16750608

Citation

Nageswara Rao, R, et al. "An Improved and Validated LC Method for Resolution of Bicalutamide Enantiomers Using Amylose Tris-(3,5-dimethylphenylcarbamate) as a Chiral Stationary Phase." Journal of Pharmaceutical and Biomedical Analysis, vol. 42, no. 3, 2006, pp. 347-53.
Nageswara Rao R, Narasa Raju A, Nagaraju D. An improved and validated LC method for resolution of bicalutamide enantiomers using amylose tris-(3,5-dimethylphenylcarbamate) as a chiral stationary phase. J Pharm Biomed Anal. 2006;42(3):347-53.
Nageswara Rao, R., Narasa Raju, A., & Nagaraju, D. (2006). An improved and validated LC method for resolution of bicalutamide enantiomers using amylose tris-(3,5-dimethylphenylcarbamate) as a chiral stationary phase. Journal of Pharmaceutical and Biomedical Analysis, 42(3), 347-53.
Nageswara Rao R, Narasa Raju A, Nagaraju D. An Improved and Validated LC Method for Resolution of Bicalutamide Enantiomers Using Amylose Tris-(3,5-dimethylphenylcarbamate) as a Chiral Stationary Phase. J Pharm Biomed Anal. 2006 Sep 26;42(3):347-53. PubMed PMID: 16750608.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An improved and validated LC method for resolution of bicalutamide enantiomers using amylose tris-(3,5-dimethylphenylcarbamate) as a chiral stationary phase. AU - Nageswara Rao,R, AU - Narasa Raju,A, AU - Nagaraju,D, Y1 - 2006/06/05/ PY - 2005/11/22/received PY - 2006/03/28/revised PY - 2006/04/10/accepted PY - 2006/6/6/pubmed PY - 2006/12/9/medline PY - 2006/6/6/entrez SP - 347 EP - 53 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 42 IS - 3 N2 - An improved HPLC method for determination of enantiomeric purity of bicalutamide in drugs and pharmaceuticals was developed and validated. Baseline separation with resolution >/=6.0 was achieved within 10 min on Chiralpak AD-H (250 mm x 4.6 mm; particle size 5 microm) column using n-hexane:2-propanol (65:35 v/v) as mobile phase at a flow rate of 1.0 ml/min at 25 degrees C. The detection was made at 270 nm using UV detector while a polarimetric detector connected in series was used for identification of enantiomers. The effects of 2-propanol, ethanol and temperature on enantioselectivity and resolution of enantiomers were evaluated. The method was validated in terms of accuracy, precision and linearity in the range of 10-250 microg/ml and the r(2) was >0.9999. The recoveries were 99.68-100.25% with <1% R.S.D. The limits of detection (LOD) and quantification (LOQ) of enantiomers were (2.4, 3.0 and 7.6, 9.3) x 10(-8)g/ml for (S)-(+)-BCT and (R)-(-)-BCT enantiomers, respectively. The method was found to be suitable for rapid determination of enantiomeric purity of bicalutamide in bulk drugs and pharmaceutical formulations. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/16750608/An_improved_and_validated_LC_method_for_resolution_of_bicalutamide_enantiomers_using_amylose_tris__35_dimethylphenylcarbamate__as_a_chiral_stationary_phase_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0731-7085(06)00318-9 DB - PRIME DP - Unbound Medicine ER -