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

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...

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Main Authors: Ethiraj Thiruvengadam, Revathi Ramadoss, Ganesan Vellaichamy
Format: Article
Language:English
Published: Universitas Gadjah Mada 2013-01-01
Series:Indonesian Journal of Pharmacy
Subjects:
Online Access:http://indonesianjpharm.farmasi.ugm.ac.id/index.php/3/article/view/509/387
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author Ethiraj Thiruvengadam
Revathi Ramadoss
Ganesan Vellaichamy
author_facet Ethiraj Thiruvengadam
Revathi Ramadoss
Ganesan Vellaichamy
author_sort Ethiraj Thiruvengadam
collection DOAJ
description 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 significant 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.
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spelling doaj.art-7cbec9524f7c4722a893671d4ca4f1102022-12-21T20:55:24ZengUniversitas Gadjah MadaIndonesian Journal of Pharmacy2338-94272338-94862013-01-012411421http://dx.doi.org/10.14499/indonesianjpharm24iss1pp14-21DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMSEthiraj Thiruvengadam0Revathi Ramadoss1Ganesan Vellaichamy2Dept of Pharmaceutics & Pharmaceutical Analysis. The Erode College of Pharmacy, Erode, Tamilnadu, 638112, IndiaDept of Pharmaceutics & Pharmaceutical Analysis. The Erode College of Pharmacy, Erode, Tamilnadu, 638112, IndiaDept of Pharmaceutics, The Erode College of Pharmacy,Erode, Tamilnadu, 638112, IndiaA 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 significant 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.http://indonesianjpharm.farmasi.ugm.ac.id/index.php/3/article/view/509/387DoxofyllineValidationHPLCUV spectroscopyComparison studiesStudent’s t-testF-test.
spellingShingle Ethiraj Thiruvengadam
Revathi Ramadoss
Ganesan Vellaichamy
DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMS
Indonesian Journal of Pharmacy
Doxofylline
Validation
HPLC
UV spectroscopy
Comparison studies
Student’s t-test
F-test.
title DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMS
title_full DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMS
title_fullStr DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMS
title_full_unstemmed DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMS
title_short DEVELOPMENT AND VALIDATION OF LIQUID CHROMATOGRAPHY AND SPECTROSCOPIC METHODS FOR THE ANALYSIS OF DOXOFYLLINE IN PHARMACEUTICAL DOSAGE FORMS
title_sort development and validation of liquid chromatography and spectroscopic methods for the analysis of doxofylline in pharmaceutical dosage forms
topic Doxofylline
Validation
HPLC
UV spectroscopy
Comparison studies
Student’s t-test
F-test.
url http://indonesianjpharm.farmasi.ugm.ac.id/index.php/3/article/view/509/387
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AT revathiramadoss developmentandvalidationofliquidchromatographyandspectroscopicmethodsfortheanalysisofdoxofyllineinpharmaceuticaldosageforms
AT ganesanvellaichamy developmentandvalidationofliquidchromatographyandspectroscopicmethodsfortheanalysisofdoxofyllineinpharmaceuticaldosageforms