DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE  ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMS

Ethiraj Thiruvengadam; Revathi Ramadoss; Ganesan Vellaichamy

doi:10.14499/indonesianjpharm24iss1pp14-21

DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMS

Ethiraj Thiruvengadam, Revathi Ramadoss, Ganesan Vellaichamy

Abstract

A high performance liquid chromatography (HPLC) and ultraviolet spectroscopic (UV) methods were developed and validated for the quantitative estimation of doxofylline (DF) in pharmaceutical dosage forms. HPLC was carried out using reversephase technique on RP-8 column with a mobile phase composed of 0.05M phosphate buffer pH 6 and acetonitrile (60:40, v/v). The mobile phase was pumped at a flow rate of 1mL/min, and detection was made at 230nm with PDA detector. UV method was performed with λ max at 270nm with apparent molar absorptive of 0.878x103 L mol-1 cm-1. Both the methods showed good linearity, recovery and precision. No spectral or chromatographic interferences from the tablet excipients were found in UV and HPLC methods. The various parameters such as linearity, precision, accuracy, specificity, and robustness, limit of detection and limit of quantization were studied according to ICH guidelines. Statistical analysis was done by student’s t-test and F-test, which showed no ignificant difference between the results of both methods. So the proposed methods could be applicable for routine analysis of DF and monitoring of the quality of marketed drugs.

Key words: Doxofylline, Validation, HPLC, UV spectroscopy, Comparison
studies, Student’s t-test, F-test.

Full Text:

Untitled

References

Akilesh G., Jaydeep SY., Swati R. and Mayuri G., 2011, Method development and hydrolytic degradation study of doxofylline by RP-HPLC and LCMS/MS, Asian J. Pharm. Anal., 1(1): 1418.

Ashu M. and Shikha P., 2010, Development and validation of rapid HPLC method

for determination of doxofylline in bulk drug and pharmaceutical dosage forms, J. Analytical Chemistry, 65(3): 293-297.

Gannu R., Bandari S., Sudka SG., Rao YM. and Shankar BP., 2007, Development and validation of a stability indicating RPHPLC method for analysis of doxofylline in human serum. Application of the method to a pharmacokinetic study, Acta Chromatographica, 19: 149-160. ICH guidelines, International Conference on Harmonisation Guidelines on Validation of Analytical Procedure: Text and Methodology Q2 (R1), Geneva; 2005, 1-8.

Joshi HR., Patel AH. and Captain AD., 2010, Spectrophotometric and reversed phase – high performance liquid chromatographic method for thr determination of doxofylline in pharmaceutical formulation, J. Young Pharmacists, 2: 289-96.

Kamila MM., Mondal N. and Ghosh, L.K., 2007, Development and validation of Spectrophotometric method for estimation of anti-asthmatic drug doxofylline in bulk and pharmaceutical formulation, Ind. J.Chem. Tech., 14:523-25.

Sagar SP., Navodaya D. and Usharani D., 2011, Spectrophotometric determination of doxofylline in tablet formulation, Asian J. Bioc. Pharm. Res., 1(3): 435-41.

Sunil kumar AVVNK., Vijaya saradhi S., Balasekaran C. and Reddy TV., 2011, Visible spectrophotometric methods for quantitative determination of doxofylline using iodine and a, a’ – bipyridyl as reagent, Oriental J. Chem., 27(2): 619-625.

Sunil kumar AVVNK., Vijaya saradhi S., Balasekaran C. and Reddy TV., 2011, Development and validation of novel analytical methods for estimation of doxofylline in bulk and dosage forms,

Euro. J. Chem., 2(3): 372-77. Venkatesan S., Giriraj P., Myvizhi S., Kathiravan P. and Rameshwar S., A simple HPLC method for quantitation of doxofylline in tablet dosage form., Int.

J.Chem. and Pharm. Scie., 1(2): 54-57

DOI: http://dx.doi.org/10.14499/indonesianjpharm24iss1pp14-21