Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms

A simple, accurate, isocratic stability indicating RP-HPLC method was developed for the determination of cefepime and amikacin in Pure and its pharmaceutical formulations. The method consists of methanol: acetonitrile:acetate buffer 75:20:05 (v/v) mobile phase at pH 5.1 with C18 column as stationary...

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Main Authors: Lella Kalyani, Chava Venkata Nageswara Rao
Format: Article
Language:English
Published: Universidade de São Paulo 2018-11-01
Series:Brazilian Journal of Pharmaceutical Sciences
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000300607&lng=en&tlng=en
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author Lella Kalyani
Chava Venkata Nageswara Rao
author_facet Lella Kalyani
Chava Venkata Nageswara Rao
author_sort Lella Kalyani
collection DOAJ
description A simple, accurate, isocratic stability indicating RP-HPLC method was developed for the determination of cefepime and amikacin in Pure and its pharmaceutical formulations. The method consists of methanol: acetonitrile:acetate buffer 75:20:05 (v/v) mobile phase at pH 5.1 with C18 column as stationary phase. The flow rate and detection wave length were 1.0 mL/min and 212 nm respectively. The linearity range for the method was found to be 2.5-25 µg/mL for amikacin and 10-100 µg/mL cefepime respectively. The developed method was validated as per ICH guidelines and the results of all the validation parameters were well within their acceptance values. Also the forced degradation studies were conducted with standard drugs. Degradation products formed during the different stress conditions were separated from both drugs. This validated method was applied for the simultaneous estimation of cefepime and amikacin in commercially available formulation sample.
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spelling doaj.art-89c6ccda3eb34beab21ed27cdc8b6b132022-12-21T21:21:41ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-97902018-11-0154310.1590/s2175-97902018000317258S1984-82502018000300607Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage formsLella KalyaniChava Venkata Nageswara RaoA simple, accurate, isocratic stability indicating RP-HPLC method was developed for the determination of cefepime and amikacin in Pure and its pharmaceutical formulations. The method consists of methanol: acetonitrile:acetate buffer 75:20:05 (v/v) mobile phase at pH 5.1 with C18 column as stationary phase. The flow rate and detection wave length were 1.0 mL/min and 212 nm respectively. The linearity range for the method was found to be 2.5-25 µg/mL for amikacin and 10-100 µg/mL cefepime respectively. The developed method was validated as per ICH guidelines and the results of all the validation parameters were well within their acceptance values. Also the forced degradation studies were conducted with standard drugs. Degradation products formed during the different stress conditions were separated from both drugs. This validated method was applied for the simultaneous estimation of cefepime and amikacin in commercially available formulation sample.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000300607&lng=en&tlng=enCefepime/method development and validationAmikacin/method development and validationRP-HPLC
spellingShingle Lella Kalyani
Chava Venkata Nageswara Rao
Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
Brazilian Journal of Pharmaceutical Sciences
Cefepime/method development and validation
Amikacin/method development and validation
RP-HPLC
title Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_full Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_fullStr Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_full_unstemmed Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_short Stability indicating RP-HPLC method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
title_sort stability indicating rp hplc method development and validation of cefepime and amikacin in pure and pharmaceutical dosage forms
topic Cefepime/method development and validation
Amikacin/method development and validation
RP-HPLC
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502018000300607&lng=en&tlng=en
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