A V ALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHO D FOR THE DETERMINATION OF DOXOFYLINE IN PURE AND PHARMACEUTICAL FORMULATIONS

A novel reverse phase high performance liquid chromatographic method (RP - HPLC) was developed and validated for the determination of doxofylline (DXF) in pharmaceutical formulations. Agilent 1100 series HPLC instrument equipped with variable wavelength programmable UV - Visible detector and a chromosil C18 (250mm x 4.6mm, 5μm) column with an auto injector was used for the present investigation. A volume of 20µL of working sta ndard of concentrati on 25µg/mL was injected into the chromatographic system, the component was separated by using the mobile phase of the mixture of potassium dihydrogen phosphate buffer of pH 5.5 and acetonitrile in the ratio 75:25(v/v) at a flow rate of 1.0 mL/min and the d etection of the components was carried out at a wavelength of 275nm. Chemstation software was used for the data acquisition through out the analysis. The system suitable parameters such a s number of theoretical plates, tailing factor and resolution were fo und to be satisfactory. The retention time of the component was found to be at 4.814 minutes. The proposed method was validated in terms of precision, accuracy, linearity, limit of detection, limit of quantification, robustness and ruggedness. The develope d method was found to be rapid, simple and sensitive hence it could be used as an alternative method in assay of the doxofylline in any pharmaceuti cal industries.

[1]  A. Mittal,et al.  Development and validation of rapid HPLC method for determination of doxofylline in bulk drug and pharmaceutical dosage forms , 2010 .

[2]  R. Mullangi,et al.  Development and validation of a HPLC method for simultaneous quantitation of gatifloxacin, sparfloxacin and moxifloxacin using levofloxacin as internal standard in human plasma: application to a clinical pharmacokinetic study. , 2008, Biomedical chromatography : BMC.

[3]  Buddhadev Layek,et al.  Development and validation of a sensitive LC-MS/MS method with electrospray ionization for quantitation of rhein in human plasma: application to a pharmacokinetic study. , 2008, Biomedical chromatography : BMC.

[4]  R. Lodha,et al.  Doxofylline: The next generation methylxanthine , 2008, Indian Journal of Pediatrics.

[5]  L. Ghosh,et al.  Development and validation of spectrophotometric method for estimation of anti-asthmatic drug doxofylline in bulk and pharmaceutical formulation , 2007 .

[6]  F. Dini,et al.  Doxofylline: A New Generation Xanthine Bronchodilator Devoid of Major Cardiovascular Adverse Effects , 2000, Current medical research and opinion.

[7]  M. Bizzarri,et al.  Solid phase extraction and high performance liquid chromatographic determination of doxophylline in plasma. , 1990, Biomedical chromatography : BMC.

[8]  A. Rossi,et al.  Doxofylline and respiratory mechanics. Short-term effects in mechanically ventilated patients with airflow obstruction and respiratory failure. , 1989, Chest.

[9]  D. Barone,et al.  Doxofylline, an antiasthmatic drug lacking affinity for adenosine receptors. , 1988, Archives internationales de pharmacodynamie et de therapie.

[10]  U. Tripathi,et al.  Novel LC Method Development and Validation for Simultaneous Determination of Montelukast and Doxofylline in Bulk and Pharmaceutical Dosage Forms , 2013 .

[11]  S. Rawat,et al.  Method Development and Acid Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS , 2011 .

[12]  S. Venkatesan,et al.  A Simple HPLC Method for Quantitation of Doxofylline in Tablet Dosage Form , 2010 .

[13]  A. Patel,et al.  Spectrophotometric and Reversed-Phase High-Performance Liquid Chromatographic Method for the Determination of Doxophylline in Pharmaceutical Formulations , 2010, Journal of young pharmacists : JYP.

[14]  Shi Xiu-qin HPLC determination of doxophylline and pharmacokinetic study in serum of patients with chronic obstructive pulmonary disease , 2009 .

[15]  S. Bandari,et al.  Development and validation of a stability-indicating RP-HPLC method for analysis of doxofylline in human serum. Application of the method to a pharmacokinetic study , 2007 .

[16]  A. Frigerio,et al.  Non-extraction HPLC method for simultaneous measurement of dyphylline and doxofylline in serum. , 1990, Clinical chemistry.