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Sci. Pharm. 2011, 79(3), 525-544; doi:10.3797/scipharm.1103-19

A Rapid, Stability Indicating RP-UPLC Method for Simultaneous Determination of Ambroxol Hydrochloride, Cetirizine Hydrochloride and Antimicrobial Preservatives in Liquid Pharmaceutical Formulation

1
Analytical Research and Development, Integrated Product Development, Dr. Reddy’s Laboratories Ltd., Bachupally, Hyderabad-500 072, India
2
P.S. Science and H.D. Patel Arts College, S.V. Campus, Kadi-382 715, Gujarat, India
*
Author to whom correspondence should be addressed.
Received: 24 March 2011 / Accepted: 26 May 2011 / Published: 26 May 2011
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Abstract

A stability indicating reversed phase ultra performance liquid chromatography (RP-UPLC) method was developed for simultaneous determination of ambroxol hydrochloride (AMB), cetirizine hydrochloride (CTZ), methylparaben (MP) and propylparaben (PP) in liquid pharmaceutical formulation. The desired chromato-graphic separation was achieved on an Agilent Eclipse plus C18, 1.8 μm (50 x 2.1 mm) column using gradient elution at 237 nm detector wavelength. The optimized mobile phase consists of a mixture of 0.01 M phosphate buffer and 0.1 % triethylamine as a solvent-A and acetonitrile as a solvent-B. The developed method separates AMB, CTZ, MP and PP in presence of twelve known impurities/degradation products and one unknown degradation product within 3.5 min. Stability indicating capability was established by forced degradation experiments and seperation of known and unknown degradation products. The lower limit of quantification was established for AMB, CTZ, MP and PP. The developed RP-UPLC method was validated according to the International Conference on Harmonization (ICH) guidelines. This validated method is applied for simultaneous estimation of AMB, CTZ, MP and PP in commercially available syrup samples. Further, the method can be extended for estimation of AMB, CTZ, MP, PP and levo-cetirizine (LCTZ) in various commercially available dosage forms.
Keywords: Cetirizine dihydrochloride; Methylparaben; Propylparaben; Levo-cetirizine; Bromhexine; Method validation; Forced degradation; Oral solution; Assay; Chromatography; UV spectra Cetirizine dihydrochloride; Methylparaben; Propylparaben; Levo-cetirizine; Bromhexine; Method validation; Forced degradation; Oral solution; Assay; Chromatography; UV spectra
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

TRIVEDI, R.K.; PATEL, M.C.; JADHAV, S.B. A Rapid, Stability Indicating RP-UPLC Method for Simultaneous Determination of Ambroxol Hydrochloride, Cetirizine Hydrochloride and Antimicrobial Preservatives in Liquid Pharmaceutical Formulation. Sci. Pharm. 2011, 79, 525-544.

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