Quantitative Determination of Levofloxacin and Ambroxol Hydrochloride in Pharmaceutical Dosage Form by Reversed-Phase High Performance Liquid Chromatography
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Vinayaka Mission College of Pharmacy Salem-636008. Tamilnadu, India
Deputy Manager, Zydus Cadila Healthcare Limited Sarkhej Bavla N.H.-8A, Changodar, Ahmedabad, Gujarat, India
Senior Scientific Assistant, Analytical Development Laboratory, Zydus Cadila Limited, Ahmedabad-382 210, Gujarat, India
Krupa M. Kothekar   

Vinayaka Mission College of Pharmacy, Salem-636008, Tamilnadu, India. Phone:+079-25434016, 09924724879
Online publication date: 2007-03-15
Publication date: 2007-03-15
Eurasian J Anal Chem 2007;2(1):21–31
The objective of this present work was to develop and validate analytical method for quantitative determination of Levofloxacin and Ambroxol hydrochloride in a new tablet formulation. Chromatographic separation of the two drugs were analyzed on a Hypersil BDS C18 column (25cm X 4.6mm, 5μm). The mobile phase constituted of Buffer: Acetonitirile: Methanol (650:250:100) with triethylamine and pH adjusted to 5.2 with dilute orthophosphoric acid was delivered at the flow rate 1.0 mL min-1. Detection was performed at 220 nm. Separation was completed within 10 min. Calibration curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 7 to 22 μg mL-1 of Levofloxacin and 50 to 150 μg/mL for Ambroxol hydrochloride respectively. The relative standard deviation (R.S.D) was found <2.0%.
Bertino J and Fish D (2000). The safety profile of the fluoroquinolones. Clinical Therapeutics 22 (7): 798.
Lorian Vand Williams L (1996) Antibiotics in Laboratory Medicine 4th Edition, p 591.
Hardman J and Goodman A (1996) The Pharmacological Basis of Therapeutics 9th Edition, McGraw-Hill NY (1996), p1065.
Belal F, Al-Majed A and Al-Obaid A M (1999) Methods of analysis of 4-quinolone antibacterial. Talanta 50(4): 765.
Ines M, Santoro R M, Singh A K, Erika R M and Hackmam K (2006) Quantitative determination of gatifloxacin, levofloxacin, lomefloxacin and pefloxacin fluoroquinolone antibiotics in pharmaceutical preparations by high-performance liquid chromatography. J Pharm Biomed Anal 40(1): 179.
Neckle U, Joukhadar C and Mayer B X (2002) Simultaneous determination of levofloxacin and ciprofloxacin in micordialysates and plasma by high-performance liquid chromatography. Anal Chim Acta 463(2): 199.
Pospíilová M, Poláek M and Jokl V (2001) Determination of ambroxol or bromhexine in pharmaceuticals by capillary isotachophoresis. J Pharm Biomed Anal 24(3): 421.
Perez-Ruiz T, Martínez-Lozano C, C. Sanz C and Bravo E (2000) Sensitive method for the determination of ambroxol in body fluids by Capillary electrophoresis and fluorescence detection. J Chromatogr B 742(1): 205.
Pérez-Ruiz T, Martínez-Lozano C, Sanz A and Bravo E (1997) Determination of bromhexine and ambroxol in pharmaceutical dosage forms, urine and blood serum. J Chromatogr B 692(1): 199.
Dinçer Z, Basan H and Göger N G (2003) Quantitative determination of ambroxol in tablets by derivative UV spectrophotometric method and HPLC. J Pharm Biomed Anal 5(1): 867.
Colombo L, Marcucci F M, Marini G M, Pierfederici P and Mussini E (1990) Determination of ambroxol in biological material by gas chromatography with Electroncapture detection. J Chromatogr B 530: 141.
Schmid J (1987) Assay of ambroxol in biological fluids by capillary gas-liquid chromatography. J Chromatogr 414: 65.
Bazylak G and Nagels L J (2003) Simultaneous high-throughput determination of clenbuterol, ambroxol and bromhexine in pharmaceutical formulations by HPLC with potentiometric detection. J Pharm Biomed Anal 32(4-5): 887.
Kim H, Yoo J Y, Han S B, Lee H J and Lee K R (2003) Determination of ambroxol in human plasma using LC-MS/MS. J Pharm Biomed Anal 32(2): 209.
Heinänen M and Barbas C (2001) Validation of an HPLC method for the quantification of ambroxol hydrochloride and benzoic acid in a syrup as pharmaceutical form stress test for stability evaluation. J Pharm Biomed Anal 24(5-6): 1005.
Koundourellis J E, Malliou E T and Broussali T A (2000) High performance liquid chromatographic determination of ambroxol in the presence of different preservative in pharmaceuticals formulations. J Pharm Biomed Anal 23 (2-3): 469.
Nobilis M, Pastera J, Svoboda D and Kvtina J, Macek K (1992) High-performance liquid chromatographic determination of ambroxol in human plasma. J Chromatgr 581(2): 251.
Brizzi V and Pasetti U (1990) High-performance liquid chromatographic determination of ambroxol in pharmaceuticals. J Pharm Biomed Anal 8(1): 107.