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Analytical Method Development for Phenylpropanolamine Hydrochloride Sustained Release Pellets


Affiliations
1 Department of Pharmaceutics, P.W. College of Pharmacy, Yavatmal, Maharashtra, India
2 Department of Pharmacology, S.K.B College of Pharmacy, Kamptee, Maharashtra, India
3 Pharma Research, Wochardt Research Centre, Aurangabad, India
4 Formulation and Development, Inventia Health Care Pvt. Ltd., Thane, India
     

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The main aim of the present study was to developed analytical method for phenylpropanolamine hydrochloride (PPH) in PPH sustained release pellets. Analysis of PPH i.e. assays and dissolution has been given in USP by HPLC method. No UV-Visible spectrometry method has been reported for the analysis of PPH. Analysis of PPH was carried out by using UV-Visible spectrometry after performing the part method validation of specificity (scanning the standard solution of PPH), filter paper validation and linearity. Sustained release pellets were fabricated containing PPH by solution/suspension layering technique. A solution of PPH was prepared in distilled water and UV spectrum was taken using Perkin Elmer, Lambda25-UV/Vis Spectrophotometer. Filter paper validation was done by filtering standard PPH solution (10 ppm) through Whatman filter paper No. 41 and absorbances of filtered solution was taken repetitively and compared with unfiltered solution at 205 nm. There was negligible changed in absorbance was obtained. The data for calibration plot showed good linear graph with r2=0.9980 for PPH. According to international conference on harmonization (ICH) guidelines, the present method was validated for precision, repeatability and recovery.

Keywords

UV-Visible Spectrophotometer, Phenylpropanolamine Hydrochloride, Sustained Release Pellets.
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  • Analytical Method Development for Phenylpropanolamine Hydrochloride Sustained Release Pellets

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Authors

Rakhee K. Kotecha
Department of Pharmaceutics, P.W. College of Pharmacy, Yavatmal, Maharashtra, India
Anand S. Surana
Department of Pharmacology, S.K.B College of Pharmacy, Kamptee, Maharashtra, India
A. V. Chandewar
Department of Pharmaceutics, P.W. College of Pharmacy, Yavatmal, Maharashtra, India
P. D. Nakhat
Pharma Research, Wochardt Research Centre, Aurangabad, India
N. P. Jogad
Formulation and Development, Inventia Health Care Pvt. Ltd., Thane, India

Abstract


The main aim of the present study was to developed analytical method for phenylpropanolamine hydrochloride (PPH) in PPH sustained release pellets. Analysis of PPH i.e. assays and dissolution has been given in USP by HPLC method. No UV-Visible spectrometry method has been reported for the analysis of PPH. Analysis of PPH was carried out by using UV-Visible spectrometry after performing the part method validation of specificity (scanning the standard solution of PPH), filter paper validation and linearity. Sustained release pellets were fabricated containing PPH by solution/suspension layering technique. A solution of PPH was prepared in distilled water and UV spectrum was taken using Perkin Elmer, Lambda25-UV/Vis Spectrophotometer. Filter paper validation was done by filtering standard PPH solution (10 ppm) through Whatman filter paper No. 41 and absorbances of filtered solution was taken repetitively and compared with unfiltered solution at 205 nm. There was negligible changed in absorbance was obtained. The data for calibration plot showed good linear graph with r2=0.9980 for PPH. According to international conference on harmonization (ICH) guidelines, the present method was validated for precision, repeatability and recovery.

Keywords


UV-Visible Spectrophotometer, Phenylpropanolamine Hydrochloride, Sustained Release Pellets.