RP-HPLC method for estimation and stability study of drotaverine HCl as per ICH guidelines

A validated stability indicating assay method was developed for the estimation of drotaverine HCl in the presence of its degradation products. The best separation of analyte was achieved in the C8 analytical column at ambient temperature using a mobile phase composition of methanol and ammonium ace...

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Autores principales: Patel, Prafull, Sahu, Kapendra, Karthikeyan, Chandrabose, Hari Narayana Moorthy, N. S., Trivedi, Piyush
Formato: Articulo
Lenguaje:Inglés
Publicado: 2011
Materias:
Farmacia
drotaverine; HCl; ICH; smooth-muscle relaxant; stability indicating assay
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/8201
http://www.latamjpharm.org/resumenes/30/4/LAJOP_30_4_1_9.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-8201
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
drotaverine; HCl; ICH; smooth-muscle relaxant; stability indicating assay
spellingShingle Farmacia
drotaverine; HCl; ICH; smooth-muscle relaxant; stability indicating assay
Patel, Prafull
Sahu, Kapendra
Karthikeyan, Chandrabose
Hari Narayana Moorthy, N. S.
Trivedi, Piyush
RP-HPLC method for estimation and stability study of drotaverine HCl as per ICH guidelines
topic_facet Farmacia
drotaverine; HCl; ICH; smooth-muscle relaxant; stability indicating assay
description A validated stability indicating assay method was developed for the estimation of drotaverine HCl in the presence of its degradation products. The best separation of analyte was achieved in the C8 analytical column at ambient temperature using a mobile phase composition of methanol and ammonium acetate (75:25) in isocratic mode. The flow rate and the detection wavelength were set at 0.9 ml/min and 308 nm, respectively. The drug gives peak at R<sub>T</sub> 7.483 min and the forced degradation studies gave three degradation products peaks in which two degradation products (R<sub>T</sub> 4.202 and 5.010 min) were obtained from alkaline hydrolysis and the third product from neutral hydrolysis of the drug and was eluted at R<sub>T</sub> 5.842 min. The limit of detection (LOD) and limit of quantitation (LOQ) of the developed method was found to be 0.4 µg /ml and 1.4 µg/ml respectively. The validation results obtained from the analysis reveals that the developed method is simple, accurate, precise, specific and selective.
format Articulo
Articulo
author Patel, Prafull
Sahu, Kapendra
Karthikeyan, Chandrabose
Hari Narayana Moorthy, N. S.
Trivedi, Piyush
author_facet Patel, Prafull
Sahu, Kapendra
Karthikeyan, Chandrabose
Hari Narayana Moorthy, N. S.
Trivedi, Piyush
author_sort Patel, Prafull
title RP-HPLC method for estimation and stability study of drotaverine HCl as per ICH guidelines
title_short RP-HPLC method for estimation and stability study of drotaverine HCl as per ICH guidelines
title_full RP-HPLC method for estimation and stability study of drotaverine HCl as per ICH guidelines
title_fullStr RP-HPLC method for estimation and stability study of drotaverine HCl as per ICH guidelines
title_full_unstemmed RP-HPLC method for estimation and stability study of drotaverine HCl as per ICH guidelines
title_sort rp-hplc method for estimation and stability study of drotaverine hcl as per ich guidelines
publishDate 2011
url http://sedici.unlp.edu.ar/handle/10915/8201
http://www.latamjpharm.org/resumenes/30/4/LAJOP_30_4_1_9.pdf
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