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Development and validation of a reversed-phase HPLC method for simultaneous estimation of ambroxol hydrochloride and azithromycin in tablet dosage form.
J Pharm Biomed Anal. 2008 Dec 15; 48(5):1481-4.JP

Abstract

A simple, precise and accurate reversed-phase liquid chromatographic method has been developed for the simultaneous estimation of ambroxol hydrochloride and azithromycin in tablet formulations. The chromatographic separation was achieved on a Xterra RP18 (250 mm x 4.6 mm, 5 microm) analytical column. A Mixture of acetonitrile-dipotassium phosphate (30 mM) (50:50, v/v) (pH 9.0) was used as the mobile phase, at a flow rate of 1.7 ml/min and detector wavelength at 215 nm. The retention time of ambroxol and azithromycin was found to be 5.0 and 11.5 min, respectively. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The linear dynamic ranges were from 30-180 to 250-1500 microg/ml for ambroxol hydrochloride and azithromycin, respectively. The percentage recovery obtained for ambroxol hydrochloride and azithromycin were 99.40 and 99.90%, respectively. Limit of detection and quantification for azithromycin were 0.8 and 2.3 microg/ml, for ambroxol hydrochloride 0.004 and 0.01 microg/ml, respectively. The developed method can be used for routine quality control analysis of titled drugs in combination in tablet formulation.

Authors+Show Affiliations

P.G. Department of Chemistry, Sir Sayyed College, P.B. No. 89, Roshan Gate, Aurangabad 431001, M.S., India. shaikh_kabeerahmed@rediffmail.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18993009

Citation

Shaikh, K A., et al. "Development and Validation of a Reversed-phase HPLC Method for Simultaneous Estimation of Ambroxol Hydrochloride and Azithromycin in Tablet Dosage Form." Journal of Pharmaceutical and Biomedical Analysis, vol. 48, no. 5, 2008, pp. 1481-4.
Shaikh KA, Patil SD, Devkhile AB. Development and validation of a reversed-phase HPLC method for simultaneous estimation of ambroxol hydrochloride and azithromycin in tablet dosage form. J Pharm Biomed Anal. 2008;48(5):1481-4.
Shaikh, K. A., Patil, S. D., & Devkhile, A. B. (2008). Development and validation of a reversed-phase HPLC method for simultaneous estimation of ambroxol hydrochloride and azithromycin in tablet dosage form. Journal of Pharmaceutical and Biomedical Analysis, 48(5), 1481-4. https://doi.org/10.1016/j.jpba.2008.09.031
Shaikh KA, Patil SD, Devkhile AB. Development and Validation of a Reversed-phase HPLC Method for Simultaneous Estimation of Ambroxol Hydrochloride and Azithromycin in Tablet Dosage Form. J Pharm Biomed Anal. 2008 Dec 15;48(5):1481-4. PubMed PMID: 18993009.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of a reversed-phase HPLC method for simultaneous estimation of ambroxol hydrochloride and azithromycin in tablet dosage form. AU - Shaikh,K A, AU - Patil,S D, AU - Devkhile,A B, Y1 - 2008/09/30/ PY - 2008/07/29/received PY - 2008/09/13/revised PY - 2008/09/18/accepted PY - 2008/11/11/pubmed PY - 2009/4/25/medline PY - 2008/11/11/entrez SP - 1481 EP - 4 JF - Journal of pharmaceutical and biomedical analysis JO - J Pharm Biomed Anal VL - 48 IS - 5 N2 - A simple, precise and accurate reversed-phase liquid chromatographic method has been developed for the simultaneous estimation of ambroxol hydrochloride and azithromycin in tablet formulations. The chromatographic separation was achieved on a Xterra RP18 (250 mm x 4.6 mm, 5 microm) analytical column. A Mixture of acetonitrile-dipotassium phosphate (30 mM) (50:50, v/v) (pH 9.0) was used as the mobile phase, at a flow rate of 1.7 ml/min and detector wavelength at 215 nm. The retention time of ambroxol and azithromycin was found to be 5.0 and 11.5 min, respectively. The validation of the proposed method was carried out for specificity, linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The linear dynamic ranges were from 30-180 to 250-1500 microg/ml for ambroxol hydrochloride and azithromycin, respectively. The percentage recovery obtained for ambroxol hydrochloride and azithromycin were 99.40 and 99.90%, respectively. Limit of detection and quantification for azithromycin were 0.8 and 2.3 microg/ml, for ambroxol hydrochloride 0.004 and 0.01 microg/ml, respectively. The developed method can be used for routine quality control analysis of titled drugs in combination in tablet formulation. SN - 0731-7085 UR - https://www.unboundmedicine.com/medline/citation/18993009/Development_and_validation_of_a_reversed_phase_HPLC_method_for_simultaneous_estimation_of_ambroxol_hydrochloride_and_azithromycin_in_tablet_dosage_form_ DB - PRIME DP - Unbound Medicine ER -