Development and validation of an HPLC analytical method for the detection and quantification of nicardipine in lipid nanoparticles

Amanda V. Fernandes, Chinna R. Pydi, Girish Pai K, Ruchi Verma, Lalit Kumar

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Abstract

An HPLC method was developed and validated as per ICH guidelines for nicardipine analysis in lipid nanoparticles. Nicardipine was quantified using methanol and 40 mM ammonium formate (pH 3.5) with a ratio 65:35% v/v and BDS C18 column as a stationary phase. Detection of drug was carried out using UV detector at 240 nm by maintaining the flow rate at 1.0 mL/min. Retention time of nicardipine was found to be 4.67 min. Linearity was constructed between 0.50 to 32.00 µg/mL. Percent relative standard deviation (%RSD) from intraday and interday precisions were found to be less than 1% and 2%, respectively. Nicardipine recovery was found from 93.94 ± 0.51 to 100.16 ± 0.18%. LOD and LOQ values were found to be 25.50 ng/mL and 77.28 ng/mL, respectively. Robustness studies also confirmed that developed method is robust with %RSD < 2%. Study concludes that developed method can be used for analysis of nicardipine in lipid nanoparticles.

Original languageEnglish
Pages (from-to)1995-2000
Number of pages6
JournalLatin American Journal of Pharmacy
Volume36
Issue number10
Publication statusPublished - 2017

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Nicardipine
Nanoparticles
High Pressure Liquid Chromatography
Lipids
formic acid
Methanol
Guidelines
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Pharmaceutical Science
  • Drug Discovery

Cite this

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title = "Development and validation of an HPLC analytical method for the detection and quantification of nicardipine in lipid nanoparticles",
abstract = "An HPLC method was developed and validated as per ICH guidelines for nicardipine analysis in lipid nanoparticles. Nicardipine was quantified using methanol and 40 mM ammonium formate (pH 3.5) with a ratio 65:35{\%} v/v and BDS C18 column as a stationary phase. Detection of drug was carried out using UV detector at 240 nm by maintaining the flow rate at 1.0 mL/min. Retention time of nicardipine was found to be 4.67 min. Linearity was constructed between 0.50 to 32.00 µg/mL. Percent relative standard deviation ({\%}RSD) from intraday and interday precisions were found to be less than 1{\%} and 2{\%}, respectively. Nicardipine recovery was found from 93.94 ± 0.51 to 100.16 ± 0.18{\%}. LOD and LOQ values were found to be 25.50 ng/mL and 77.28 ng/mL, respectively. Robustness studies also confirmed that developed method is robust with {\%}RSD < 2{\%}. Study concludes that developed method can be used for analysis of nicardipine in lipid nanoparticles.",
author = "Fernandes, {Amanda V.} and Pydi, {Chinna R.} and {Pai K}, Girish and Ruchi Verma and Lalit Kumar",
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T1 - Development and validation of an HPLC analytical method for the detection and quantification of nicardipine in lipid nanoparticles

AU - Fernandes, Amanda V.

AU - Pydi, Chinna R.

AU - Pai K, Girish

AU - Verma, Ruchi

AU - Kumar, Lalit

PY - 2017

Y1 - 2017

N2 - An HPLC method was developed and validated as per ICH guidelines for nicardipine analysis in lipid nanoparticles. Nicardipine was quantified using methanol and 40 mM ammonium formate (pH 3.5) with a ratio 65:35% v/v and BDS C18 column as a stationary phase. Detection of drug was carried out using UV detector at 240 nm by maintaining the flow rate at 1.0 mL/min. Retention time of nicardipine was found to be 4.67 min. Linearity was constructed between 0.50 to 32.00 µg/mL. Percent relative standard deviation (%RSD) from intraday and interday precisions were found to be less than 1% and 2%, respectively. Nicardipine recovery was found from 93.94 ± 0.51 to 100.16 ± 0.18%. LOD and LOQ values were found to be 25.50 ng/mL and 77.28 ng/mL, respectively. Robustness studies also confirmed that developed method is robust with %RSD < 2%. Study concludes that developed method can be used for analysis of nicardipine in lipid nanoparticles.

AB - An HPLC method was developed and validated as per ICH guidelines for nicardipine analysis in lipid nanoparticles. Nicardipine was quantified using methanol and 40 mM ammonium formate (pH 3.5) with a ratio 65:35% v/v and BDS C18 column as a stationary phase. Detection of drug was carried out using UV detector at 240 nm by maintaining the flow rate at 1.0 mL/min. Retention time of nicardipine was found to be 4.67 min. Linearity was constructed between 0.50 to 32.00 µg/mL. Percent relative standard deviation (%RSD) from intraday and interday precisions were found to be less than 1% and 2%, respectively. Nicardipine recovery was found from 93.94 ± 0.51 to 100.16 ± 0.18%. LOD and LOQ values were found to be 25.50 ng/mL and 77.28 ng/mL, respectively. Robustness studies also confirmed that developed method is robust with %RSD < 2%. Study concludes that developed method can be used for analysis of nicardipine in lipid nanoparticles.

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