Abstract A key aspect of pharmaceutical analysis that guarantees the efficacy, safety, and quality of medication items is impurity profiling. It involves the Identification and quantification of Impurities that may arise during synthesis. In this research a Novel RP-HPLC method was developed and validated including separation of Impurities and quantification of Brompheniramine Maleate. The separation of all three main components and Impurities was achieved using Gradient mode with the use of UV and PDA detector at 260nm wavelength. In port A of mobile phase 100% Potassium di-hydrogen phosphate buffer pH 3.0 was kept and in port B 100% Acetonitrile was kept. Separation was achieved by using Sunniest C18 column having dimensions 150 x 4.6mm, 3µm. 1.0ml/min flow rate was set with column temperature 30°C. Total run time was 40 min showed separation of all three components i.e. Brompheniramine Maleate (BPM), Dextromethorphan HBr (DMP), Phenylephrine HCl (PPN) and BPM’s impurities. A linear relationship (r = 0.99) revealed for all known analyte with concentration range of LOQ to 150%. Recovery study specifies the accuracy of the method. The repeatability determined that the method is precise enough within acceptance limit. Excellent linearity, accuracy, specificity, precision, robustness, LOD, LOQ and system applicability results are shown by the proposed approach. Moreover, the study on forced degradation showed that the method was stable suggesting.
Pataskar et al. (Tue,) studied this question.
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