Brompheniramine 12mg capsules

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 the 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 a UV and PDA detector at 260 nm wavelength. In port A of the 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 a Sunniest C18 column having dimensions 150 × 4.6 mm, 3 μm. 1.0 ml/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) retention time (RT) − 23.64, Dextromethorphan HBr (DMP) RT – 25.22, Phenylephrine HCl (PPN) RT – 3.66 and BPM’s impurities such as Chlorpheniramine related compound B (Impurity A) RT – 22.81, Chlorpheniramine (Impurity B) RT – 11.06, and Pheniramine (Impurity C) RT – 14.96 with resolution ≥ 2.0. A linear relationship (r = 0.99) was revealed for all known analytes with a concentration range of LOQ to 150%. The recovery study specifies the accuracy of the method obtained in a range of 95%-105%. The repeatability determined that the method is precise enough within the acceptance limit of 80%-120%. Excellent linearity, accuracy, specificity, precision, robustness, LOD, LOQ and system applicability results are shown by the proposed approach.

Abstract licence: CC BY-NC-ND 4.0

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.

Abstract licence: CC BY 4.0

Comtrex® tablets composed of paracetamol, pseudoephedrine and brompheniramine are widely used for relieving symptoms related to common cold. This study has overcome the challenging dosage form ratio (250:15:1) and proposed chromatographic methods for analyzing the ternary combination were utilized displaying different apparatus, solvents and sensitivity ranges. Three chromatographic methods namely thin layer chromatography (TLC), high performance liquid chromatography with ultra-violet detection (HPLC–UV) and ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS) were developed and validated for the simultaneous determination of the three drugs. Concerning the TLC method, aluminum TLC plates pre-coated with silica gel 60F254 were used and methanol:water:ammonia (9:1:0.1, v/v/v) was applied as a mobile phase; scanning of the plates was carried out at 254 nm. For the HPLC–UV method C18 column was used with an isocratic elution mobile phase composed of water:acetonitrile (75:25, v/v; pH 3.2) and the detection was at 210 nm. For the UPLC-MS/MS method; separation was performed on a UPLC-BEH C18 column with methanol: 0.1% ammonium formate (60:40, v/v) as the mobile phase utilizing diphenhydramine as an internal standard and mass spectrometry was used for detection. The methods were simple, sensitive, accurate and precise. Statistical analysis revealed no significant difference from the reported methods in regard to accuracy and precision.

Abstract licence: CC BY 4.0