Determination of prilocaine HCl in bulk drug and pharmaceutical formulation by GC-NPD method

Abstract

The novel analytical method was developed and validated for determination of prilocaine HCl in bulk drug and pharmaceutical formulation by gas chromatography-nitrogen phosphorus detection (GC-NPD). The chromatographic separation was performed using a HP-5MS column. The calibration curve was linear over the concentration range of 40-1000 ng ml-1 with a correlation coefficient of 0.9998. The limits of detection (LOD) and quantification (LOQ) of method were 10 ng ml-1 and 35 ng ml-1, respectively. The within-day and between-day precision, expressed as the percent relative standard deviation (RSD%) was less than 5.0%, and accuracy (percent relative error) was better than 4.0%. The developed method can be directly and easily applied for determination of prilocaine HCl in bulk drug and pharmaceutical formulation using internal standard methodology.

Keywords

• GC-NPD
• prilocaine HCl
• pharmaceutical formulation
• validation