Analytical method development and validation of RP-HPLC method for simultaneous estimation of N-acetyl cysteine and cefexime from its fixed dose combination

Janhavi Dabir, Elizabeth Mary Mathew, Sudheer Moorkoth

Research output: Contribution to journalArticle

Abstract

A simple novel validated isocratic reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of N-acetyl cysteine (NAC) and cefexime from its fixed dose combination (FDC). The fixed dose combination of NAC and cefexime is used in the treatment of chronic obstructive pulmonary disease. Separation was achieved on Acclaim C18 (150 mm x 4mm.) with 25 mM potassium dihydrogen phosphate (pH 2.7) and acetonitrile in the ratio 90:10 v/v. The mobile phase was pumped at 1mL/min and quantification was carried out at 220 nm using a UV detector. The retention time of NAC and cefexime was 2.7min and 11.47 min respectively. The method was validated as per ICH Q2R1 guidelines. The method demonstrated linearity from10-90 μg/ml and accuracy was between 101.16-101.96%. The precision of the method was less than 2% in all the cases. The method was further applied in the assay of marketed formulation.

Original languageEnglish
Pages (from-to)835-842
Number of pages8
JournalResearch Journal of Pharmacy and Technology
Volume9
Issue number7
DOIs
Publication statusPublished - 01-07-2016

Fingerprint

Cysteine
High Pressure Liquid Chromatography
Chronic Obstructive Pulmonary Disease
Guidelines

All Science Journal Classification (ASJC) codes

  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Pharmacology (medical)

Cite this

@article{d531d35a42ef42ebbe3937b713aca5b1,
title = "Analytical method development and validation of RP-HPLC method for simultaneous estimation of N-acetyl cysteine and cefexime from its fixed dose combination",
abstract = "A simple novel validated isocratic reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of N-acetyl cysteine (NAC) and cefexime from its fixed dose combination (FDC). The fixed dose combination of NAC and cefexime is used in the treatment of chronic obstructive pulmonary disease. Separation was achieved on Acclaim C18 (150 mm x 4mm.) with 25 mM potassium dihydrogen phosphate (pH 2.7) and acetonitrile in the ratio 90:10 v/v. The mobile phase was pumped at 1mL/min and quantification was carried out at 220 nm using a UV detector. The retention time of NAC and cefexime was 2.7min and 11.47 min respectively. The method was validated as per ICH Q2R1 guidelines. The method demonstrated linearity from10-90 μg/ml and accuracy was between 101.16-101.96{\%}. The precision of the method was less than 2{\%} in all the cases. The method was further applied in the assay of marketed formulation.",
author = "Janhavi Dabir and Mathew, {Elizabeth Mary} and Sudheer Moorkoth",
year = "2016",
month = "7",
day = "1",
doi = "10.5958/0974-360X.2016.00158.X",
language = "English",
volume = "9",
pages = "835--842",
journal = "Research Journal of Pharmacy and Technology",
issn = "0974-3618",
publisher = "A and V Publication",
number = "7",

}

TY - JOUR

T1 - Analytical method development and validation of RP-HPLC method for simultaneous estimation of N-acetyl cysteine and cefexime from its fixed dose combination

AU - Dabir, Janhavi

AU - Mathew, Elizabeth Mary

AU - Moorkoth, Sudheer

PY - 2016/7/1

Y1 - 2016/7/1

N2 - A simple novel validated isocratic reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of N-acetyl cysteine (NAC) and cefexime from its fixed dose combination (FDC). The fixed dose combination of NAC and cefexime is used in the treatment of chronic obstructive pulmonary disease. Separation was achieved on Acclaim C18 (150 mm x 4mm.) with 25 mM potassium dihydrogen phosphate (pH 2.7) and acetonitrile in the ratio 90:10 v/v. The mobile phase was pumped at 1mL/min and quantification was carried out at 220 nm using a UV detector. The retention time of NAC and cefexime was 2.7min and 11.47 min respectively. The method was validated as per ICH Q2R1 guidelines. The method demonstrated linearity from10-90 μg/ml and accuracy was between 101.16-101.96%. The precision of the method was less than 2% in all the cases. The method was further applied in the assay of marketed formulation.

AB - A simple novel validated isocratic reverse phase high performance liquid chromatographic method has been developed for the simultaneous estimation of N-acetyl cysteine (NAC) and cefexime from its fixed dose combination (FDC). The fixed dose combination of NAC and cefexime is used in the treatment of chronic obstructive pulmonary disease. Separation was achieved on Acclaim C18 (150 mm x 4mm.) with 25 mM potassium dihydrogen phosphate (pH 2.7) and acetonitrile in the ratio 90:10 v/v. The mobile phase was pumped at 1mL/min and quantification was carried out at 220 nm using a UV detector. The retention time of NAC and cefexime was 2.7min and 11.47 min respectively. The method was validated as per ICH Q2R1 guidelines. The method demonstrated linearity from10-90 μg/ml and accuracy was between 101.16-101.96%. The precision of the method was less than 2% in all the cases. The method was further applied in the assay of marketed formulation.

UR - http://www.scopus.com/inward/record.url?scp=85033483981&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85033483981&partnerID=8YFLogxK

U2 - 10.5958/0974-360X.2016.00158.X

DO - 10.5958/0974-360X.2016.00158.X

M3 - Article

VL - 9

SP - 835

EP - 842

JO - Research Journal of Pharmacy and Technology

JF - Research Journal of Pharmacy and Technology

SN - 0974-3618

IS - 7

ER -