Abstract
<p>ABSTRACT<br />Objective: To develop an accurate, precise and linear gas chromatography-mass spectrometric (GC-MS) selected-ion-monitoring (SIM) method for<br />quantitative estimation of 2-chloro methyl propionate (2-CMP), 1,4-dibromo butane and para anisic aldehyde (PAA) as an genotoxic impurities in<br />mebeverine HCl API (MEB) at ppm level and validated as per International Council of Harmonization (ICH) guidelines.<br />Methods: This method used in SIM mode mass selective detection was developed and validated for the trace level analysis of three impurities. All<br />these three impurities are simultaneously determined by a GC-MS method using VF-624 Capillary column (60 m×0.32 mm×1.80 µm) with Helium as<br />carrier gas and a flow rate of 2.0 mL/minutes. Chromatographic separation of 2-CMP, 1,4-DBB, and PAA was achieved in 7.91, 13.69, 18.45 minutes<br />and m/z values were 63, 55, 135 on SIM mode.<br />Results: The method was linear for 2-CMP, 1,4-DBB and PAA in mebeverine HCl 1.90 µg/ml to 7.5 µg/ml, respectively. The coefficient of correlation<br />(r<br />) for the 2-CMP, 1,4-DBB and PAA was better than 0.999. The limit of detection obtained was 0.28, 0.35, 0.22 µg/ml and the limit of quantification<br />(LOQ) obtained was 0.85, 1.06, 0.66 µg/ml. The method was fully validated, complying Food and Drug Administration, ICH and European Medicines<br />Agency guidelines. Furthermore, verified precision, accuracy, LOQ precision, LOQ accuracy, ruggedness, and robustness.<br />2<br />Conclusion: The proposed method is specific, accurate, precise, linear, rugged and robust for the determination of the three genotoxic impurities in<br />API of mebeverine HCl, and hence, is of wide applicability in pharmaceutical industries.<br />Keywords: 2-chloro methyl propionate, 1,4-dibromo butane, Para anisic aldehyde, Mebeverine HCl, Gas chromatography-mass spectrometric, Method<br />development, Method validation.</p>
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