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Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods.
J Pharm Biomed Anal. 2002 Jul 20; 29(4):593-607.JP

Abstract

High Performance Liquid Chromatographic (HPLC) and Micellar Electrokinetic Chromatographic (MEKC) methods have been developed for the determination of pioglitazone, a new englycemic antidiabetic agent. Pioglitazone and its unsaturated impurity were separated by MEKC in less than 7 min using a 43 cm x 50 microm i.d. uncoated fused-silica capillary with extended light path for better sensitivity (25 kV at 30 degrees C) and a background electrolyte (BGE) consisting of 20% acetonitrile (v/v) in 20 mM sodium borate buffer pH 9.3 containing 50 mM sodium dodecyl sulphate (SDS). The influence of various parameters on the separation such as pH of the buffer, SDS concentration, buffer concentration, organic modifiers, temperature and voltage were investigated. The MEKC method was compared with HPLC method using a 5 microm symmetry C18 column (250 x 4.6 mm i.d.) eluted with a mobile phase consisting of a mixture of 50% (v/v) acetonitrile and 10 mM potassium dihydrogen phosphate buffer, adjusting the pH to 6.0 with 0.1 M KOH. The HPLC method is capable of detecting all process related compounds, which may be present at trace levels in finished products. Both methods were fully validated and a comparison was made. The results confirm that the methods are highly suitable for its intended purpose.

Authors+Show Affiliations

Department of Analytical Research, Dr. Reddy's Research Foundation, Bollaram Road, Miyapur, 500 050, Hyderabad, India.No affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

12093488

Citation

Radhakrishna, T, et al. "Determination of Pioglitazone Hydrochloride in Bulk and Pharmaceutical Formulations By HPLC and MEKC Methods." Journal of Pharmaceutical and Biomedical Analysis, vol. 29, no. 4, 2002, pp. 593-607.
Radhakrishna T, Sreenivas Rao D, Om Reddy G. Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods. J Pharm Biomed Anal. 2002;29(4):593-607.
Radhakrishna, T., Sreenivas Rao, D., & Om Reddy, G. (2002). Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods. Journal of Pharmaceutical and Biomedical Analysis, 29(4), 593-607.
Radhakrishna T, Sreenivas Rao D, Om Reddy G. Determination of Pioglitazone Hydrochloride in Bulk and Pharmaceutical Formulations By HPLC and MEKC Methods. J Pharm Biomed Anal. 2002 Jul 20;29(4):593-607. PubMed PMID: 12093488.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Determination of pioglitazone hydrochloride in bulk and pharmaceutical formulations by HPLC and MEKC methods. AU - Radhakrishna,T, AU - Sreenivas Rao,D, AU - Om Reddy,G, PY - 2002/7/3/pubmed PY - 2002/10/22/medline PY - 2002/7/3/entrez SP - 593 EP - 607 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 29 IS - 4 N2 - High Performance Liquid Chromatographic (HPLC) and Micellar Electrokinetic Chromatographic (MEKC) methods have been developed for the determination of pioglitazone, a new englycemic antidiabetic agent. Pioglitazone and its unsaturated impurity were separated by MEKC in less than 7 min using a 43 cm x 50 microm i.d. uncoated fused-silica capillary with extended light path for better sensitivity (25 kV at 30 degrees C) and a background electrolyte (BGE) consisting of 20% acetonitrile (v/v) in 20 mM sodium borate buffer pH 9.3 containing 50 mM sodium dodecyl sulphate (SDS). The influence of various parameters on the separation such as pH of the buffer, SDS concentration, buffer concentration, organic modifiers, temperature and voltage were investigated. The MEKC method was compared with HPLC method using a 5 microm symmetry C18 column (250 x 4.6 mm i.d.) eluted with a mobile phase consisting of a mixture of 50% (v/v) acetonitrile and 10 mM potassium dihydrogen phosphate buffer, adjusting the pH to 6.0 with 0.1 M KOH. The HPLC method is capable of detecting all process related compounds, which may be present at trace levels in finished products. Both methods were fully validated and a comparison was made. The results confirm that the methods are highly suitable for its intended purpose. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/12093488/Determination_of_pioglitazone_hydrochloride_in_bulk_and_pharmaceutical_formulations_by_HPLC_and_MEKC_methods_ DB - PRIME DP - Unbound Medicine ER -