method is simple, precise and accurate for the determination of doxofylline and
its degradation product in bulk drug and pharmaceutical preparations. It was
validated for parameters like precision, accuracy, specificity, ruggedness and
robustness and was found to yield good results. The method can therefore be
applied for routine quality control analysis of doxofylline in pharmaceutical
extend their sincere thanks to Dr. Reddy’s Laboratory, Hyderabad, India for
providing gift sample of pure doxofylline.
Cirillo R, Barone D,
Franzone JS. Doxofylline, an antiasthmatic drug lacking affinity for adenosine
receptors. Arch Int Pharmacodyn Ther. 1988; 295:221–237.
Gannu R, Bandari S, Sudke SG, Rao YM, Shankar BP.
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. Acta Chromatogr. 2007; 19:149-157.
Sreenivas N, Narasu ML, Shankar BP, Mullangi R.
Development and validation of a sensitive LCMS/MS method with electrospray
ionization for quantitation of doxofylline in human serum: application to a
clinical pharmacokinetic study. Biomed Chromatogr. 2008; 22(6):654-661.
Lagana A, Bizzarri M, Marino A, Mancini M. Solid
phase extraction and high performance liquid chromatographic determination of
doxofylline in plasma. Biomed Chromatogr. 1990; 4(5):205–207.
Unping G, Hongbo W, Yinjie F. Determination of
Doxofylline in Plasma by SPE-HPLC. China Pharmacist, 2005; 4.
Tagliaro F, Dorizzi R, Frigerio A, Marigo M.
Non-extraction HPLC method for simultaneous measurement of dyphylline and
doxofylline in serum. Clin Chem. 1990; 36(1):113-115.
Yifang L, Weimin S, Jie S, Zhongjuan1S, Yun X.
Determination of Theophylline and
Doxofylline in Human Plasma by HPLC. Chin J Pharm. 2010; 2.
Shujun W, Lifeng W, Jianhua X, Kangshou Z.
Determination of doxofylline concentration in human serum by HPLC. Chin J Clin
Pharm. 2003; 6.
Yanggui X, Yishan B, Zhenmei H, Chunyang W, Jun L,
Zhongyang G. Determination of Doxofylline Concentration in Plasma by RP-HPLC.
China Pharmacist. 2002; 8.
Yinxiu Y, Wenxing P, Huande L. Bioequivalence of
Doxofylline in Healthy Volunteers. J China Pharma University. 1998; 5.
Quan-cheng K, Duo-lu L, Xiu-qin S. HPLC
determination of doxofylline and pharmacokinetic study in serum of patients
with chronic obstructive pulmonary disease. Chin J Pharm Anal. 2009; 5.
Kamila MM, Mondal N, Ghosh LK. Development and
validation of spectrophotometric method for estimation of antiasthmatic drug
doxofylline in bulk and pharmaceutical formulation, Indian J Chem Tech. 2007;
Joshi HR, Patel AH, Captain AD. Spectrophotometric
and Reversed-Phase High- Performance Liquid Chromatographic Method for the
Determination of Doxofylline in Pharmaceutical Formulation. J Young Pharm. 2010; 1:141-145.
Mittal A, Parmar S. Development and validation of
rapid HPLC method for determination of doxofylline in bulk drug and
pharmaceutical dosage forms. J Ana Chem. 2010; 65:293-297.
Zi-li X. Determination of doxofylline in
doxofylline injection by GC method. Anhui Med Pharm J. 2006; 9.
Patre NG, Sathiyanarayanan L,
Mahadik MV, Dhaneshwar SR. A validated, stability indicating HPTLC method for
analysis of doxofylline. J Planar Chromatogr- Mod TLC. 2009; 22(5):345-348.
17. Rao RN, Naidu ChG, Prasad KG, Santhakumar B, Saida S. Development and
validation of a stability indicating assay of doxofylline by RP-HPLC:
ESI-MS/MS, ¹H and ¹³C NMR spectroscopic characterization of degradation
products and process related impurities. J Pharm Biomed
18. Gupta A, Rawat S, Gandhi M, Yadav JS. Method Development and Acid
Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS; Asian J Pharm Ana. 2011;
19. Chauhan PS, Panchal VU, Patel GF. Development &
validation of derivative spectrophotometric method for simultaneous estimation
of doxofylline & ambroxol HCl in their bulk dosage form, Universal J.
Pharm. 2013; 02(01):154-159.
Jain A, Khandhar AP, Maheshwari S, Maliwal D.
Analytical Method Development, Validation and Comparison of Spectrophotometric
and Stability Indicating HPLC Methods for the Simultaneous Estimation of
Doxofylline and Montelukast in Pharmaceutical Dosage Form. AAPS Annual Meeting
and Exposition November 10, 2009.
International Conference on Harmonization of Technical Requirements for the Registration
of Pharmaceuticals for Human Use, Validation of analytical procedures, ICH-Q2A,
22. International Conference on Harmonization of Technical Requirements for the
Registration of Pharmaceuticals for Human Use, Validation of analytical
procedures: Methodology, ICH-Q2B, Geneva (1996).