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A stability-indicating HPLC method for the determination of glucosamine in pharmaceutical formulations.
J Pharm Biomed Anal. 2004 May 28; 35(3):625-31.JP

Abstract

A stability-indicating high performance liquid chromatographic (HPLC) method was developed for the assay of glucosamine in bulk forms and solid dosage formulations. The HPLC separation was achieved on a Phenomenex Luna amino column (150 mm x 4.6 mm, i.d., 5 microm particle size) using a mobile phase of acetonitrile-phosphate buffer (75:25, v/v, pH 7.50) at a flow rate of 1.5 ml min(-1) and UV detection at 195 nm. The method was validated for specificity, linearity, solution stability, accuracy, precision, limit of detection, and limit of quantitation. The detector response for glucosamine hydrochloride was linear over the selected concentration range from 1.88 to 5.62 mg ml(-1) with a correlation coefficient 0.9998. The accuracy was between 98.9 and 100.5%. The precision (R.S.D.) amongst six sample preparations was 1.1%. The limit of detection and the limit of quantitation are 0.037 and 0.149 mg ml(-1), respectively. The sample and standard solutions were stable for 1 week. The method was successfully used for analysis of active-excipient compatibility samples used for development of a solid dosage formulation in our laboratory and subsequent stability studies. The method was also used for the analysis of glucosamine in several commercially available solid dosage forms.

Authors+Show Affiliations

New Product Development, GlaxoSmithKline Consumer Healthcare, Parsippany, NJ 07054, USA. yu.y.shao@gsk.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15137989

Citation

Shao, Yu, et al. "A Stability-indicating HPLC Method for the Determination of Glucosamine in Pharmaceutical Formulations." Journal of Pharmaceutical and Biomedical Analysis, vol. 35, no. 3, 2004, pp. 625-31.
Shao Y, Alluri R, Mummert M, et al. A stability-indicating HPLC method for the determination of glucosamine in pharmaceutical formulations. J Pharm Biomed Anal. 2004;35(3):625-31.
Shao, Y., Alluri, R., Mummert, M., Koetter, U., & Lech, S. (2004). A stability-indicating HPLC method for the determination of glucosamine in pharmaceutical formulations. Journal of Pharmaceutical and Biomedical Analysis, 35(3), 625-31.
Shao Y, et al. A Stability-indicating HPLC Method for the Determination of Glucosamine in Pharmaceutical Formulations. J Pharm Biomed Anal. 2004 May 28;35(3):625-31. PubMed PMID: 15137989.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A stability-indicating HPLC method for the determination of glucosamine in pharmaceutical formulations. AU - Shao,Yu, AU - Alluri,Rama, AU - Mummert,Mike, AU - Koetter,Uwe, AU - Lech,Stanley, PY - 2003/10/17/received PY - 2004/01/15/revised PY - 2004/01/20/accepted PY - 2004/5/13/pubmed PY - 2004/12/28/medline PY - 2004/5/13/entrez SP - 625 EP - 31 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 35 IS - 3 N2 - A stability-indicating high performance liquid chromatographic (HPLC) method was developed for the assay of glucosamine in bulk forms and solid dosage formulations. The HPLC separation was achieved on a Phenomenex Luna amino column (150 mm x 4.6 mm, i.d., 5 microm particle size) using a mobile phase of acetonitrile-phosphate buffer (75:25, v/v, pH 7.50) at a flow rate of 1.5 ml min(-1) and UV detection at 195 nm. The method was validated for specificity, linearity, solution stability, accuracy, precision, limit of detection, and limit of quantitation. The detector response for glucosamine hydrochloride was linear over the selected concentration range from 1.88 to 5.62 mg ml(-1) with a correlation coefficient 0.9998. The accuracy was between 98.9 and 100.5%. The precision (R.S.D.) amongst six sample preparations was 1.1%. The limit of detection and the limit of quantitation are 0.037 and 0.149 mg ml(-1), respectively. The sample and standard solutions were stable for 1 week. The method was successfully used for analysis of active-excipient compatibility samples used for development of a solid dosage formulation in our laboratory and subsequent stability studies. The method was also used for the analysis of glucosamine in several commercially available solid dosage forms. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/15137989/A_stability_indicating_HPLC_method_for_the_determination_of_glucosamine_in_pharmaceutical_formulations_ DB - PRIME DP - Unbound Medicine ER -