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

Atila Alptug (Ataturk University, Faculty of Pharmacy, Department of Analytical Chemistry, Erzurum, Turkey)
Kadioglu Yucel (Ataturk University, Faculty of Pharmacy, Department of Analytical Chemistry, Erzurum, Turkey)

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