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THE PHARMA REVIEW (JULY AUGUST 2020)

A New Investigational Method for Quantification and Validation of Analytical Method for Cefixime and Erdosteine by UPLC with Photo Diode Array Detector in Bulk and Formulation. Application to The Estimation of Product Traces

Tammisetty Mohanrao1*, Challa Balasekhara Reddy2 & Puttagunta Srinivasa Babu3

Introduction: Specific and innovative method was developed and validated for the identification and quantification of Cefixime and Erdosteine in the bulk and formulation samples by UPLC with the PDA detector. The analytical technique was with the Buffer (pH: 7.0): Methanol, (65:35%, v/v) using the Sunfire C18, 5, 46mmX150mm analytical column with analysis time of six minutes. The flow of mobile phase through column was 1.0 ml/min. The sample volume was 10 L. The detection was carried at 254 nm in photo diode array detector. The retention times of Cefixime and Erdosteine were 2.012 min and 3.122min. The curve indicates correlation coefficient (r2) was superior by having the value 1.000 with linear range of 20.0ng/ml-200.0 ng/ml for Cefixime. And for Erdosteine 30 ng/ml-300.0 ng/ml.The correlation coefficient (r2) for Erdosteine found 1.000. The LOQ for the Cefixime and Erdosteine was 20ng/ml and 30ng/ml .And the LOD for the Cefixime and Erdosteine was 1.0 ng/ml and 1.5ng/ml. The developed method was applied for the bulk and formulation and Equipment cleaning sample.

 

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