Volume-5, Issue-4, Oct-2014 1108 Available Online at www.ijppronline.in International Journal Of Pharma Professional’s Research Research Article DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF LEVOCETIRIZINE DIHYDROCHLORIDE AND AMBROXOL HYDROCHLORIDE IN ORAL SYRUP FORMULATION Tholla haseena banu*, C.gopinath, vineet kumar, dipankar karmakar, Achhrish goel ISSN NO:0976-6723 Annamacharya college of pharmacy Arvind Remedies Limited, Chennai Abstract The present work describes a simple, precise and accurate RP-HPLC method for estimation of Levocetirizine Di-Hydrochloride and Ambroxol Hydrochloride in Oral syrup dosage form. The separation was achieved by using Sun fire column (C18) and mixture of acetonitrile and buffer in the ratio of 50:50 (ammonium dihydrogen phosphate dissolved in HPLC grade water pH 6.0 ±0.05 with Triethylamine as mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 230 nm. The retention time of Levocetirizine Di-Hydrochloride & Ambroxol Hcl were found to be 4.239 &2.631min. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision, accuracy and specificity. The proposed method provides an accurate and precise quality control tool for routine analysis of Levocetirizine Di-Hydrochloride & Ambroxol Hcl in Oral syrup dosage form. Keywords: - : Levocetirizine Di-Hydrochloride , Ambroxol HCL, Validation Introduction High Performance Liquid Chromatography, or HPLC, is the most common analytical separation tool and is used in many aspects of drug manufacture and research. HPLC is used for the Qualitative and quantitative analysis of unknown mixtures – determining what is there, and how much.Separation of mixtures for later analysis.In this stationary phase is less polar than the mobile phase and isusually comprised of spherical silica particles (typically, 3– 5μm in diameter). Typicalmobile phases used in RP- HPLC consist of mixtures of aqueous buffers mixedwith water-miscible organic solvents, such as methanol and acetonitrile. Inaddition to modified silica stationary phases, other new developments inRP-HPLC are now available, e.g. porous polymeric, carbon and mixed mobile phases [1]. Incidence of allergic diseases such as allergic rhinitis and asthma is increasing to epidemic proportions (allergic rhinitis: 10-50%; and asthma: 5-15%), both in the developed and the developing world, with a histamine receptors [4]. reduced quality of life of the patients, lower productivity and increasing medical costs. Rhinitis frequently precedes asthma, and treating allergic rhinitis has beneficial effects on asthma, suggesting that upper airway disease is a risk factor for asthma. [2]. Histamine plays a vital role in the allergic immediate reaction. The biological effects of histamine in the allergic reaction are mediated through H1 receptors. H1 antihistamines work as inverse agonists and suppress the effects of histamine.levocetirizine is used to treat allergic reactions and chronic idiopathic urticaria having molecular formula C21H25ClN2O3.2HCl [3]. Levocetirizine di-hydrochloride is chemically 2-(2- {4-[(R)-(4 chlorophenyl) (phenyl)methyl]piperazin- 1-yl}ethoxy)acetic acid is a third-generation non- sedative antihistamine, developed from the second- generation antihistamine cetirizine. Levocetirizine is the active enantiomer of cetirizine. Levocetirizine is non-sedative anti-histaminic and competitive inhibitors of H1 receptors and acts by blocking
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Volume-5, Issue-4, Oct-2014
1108
Available Online at www.ijppronline.in
International Journal Of Pharma Professional’s
Research
Research Article
DEVELOPMENT AND VALIDATION OF RP-HPLC
METHOD FOR SIMULTANEOUS ESTIMATION OF
LEVOCETIRIZINE DIHYDROCHLORIDE AND
AMBROXOL HYDROCHLORIDE IN ORAL SYRUP
FORMULATION
Tholla haseena banu*, C.gopinath, vineet kumar,
dipankar karmakar, Achhrish goel
ISSN NO:0976-6723
Annamacharya college of pharmacy
Arvind Remedies Limited, Chennai
Abstract The present work describes a simple, precise and accurate RP-HPLC method for estimation of
Levocetirizine Di-Hydrochloride and Ambroxol Hydrochloride in Oral syrup dosage form. The separation
was achieved by using Sun fire column (C18) and mixture of acetonitrile and buffer in the ratio of 50:50
(ammonium dihydrogen phosphate dissolved in HPLC grade water pH 6.0 ±0.05 with Triethylamine as
mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 230 nm. The retention time of
Levocetirizine Di-Hydrochloride & Ambroxol Hcl were found to be 4.239 &2.631min. The accuracy and
reliability of the proposed method was ascertained by evaluating various validation parameters like
linearity, precision, accuracy and specificity. The proposed method provides an accurate and precise
quality control tool for routine analysis of Levocetirizine Di-Hydrochloride & Ambroxol Hcl in Oral syrup