Stability-Indicating RP-HPLC Determination of Acetylsalicylic Acid, Dextromethorphan Hydrobromide, Phenylephrine Bitartrate, and Chlorpheniramine Maleate in an Effervescent Tablet Formulation
Randomized trial develops a stability-indicating method for quantifying four active ingredients in effervescent tablets, indicating its utility for quality control.
Key Points
The aim is to create and validate a reliable reversed-phase HPLC method for quantifying specific active ingredients and their impurities in effervescent tablets.
Used InertSustain C8 column for chromatographic separation with dual-wavelength detection.
Validated the method per ICH Q2(R2) for specificity, linearity, accuracy, and precision.
Conducted forced degradation studies to confirm stability-indicating capability.
Achieved baseline resolution for all analytes within a single chromatographic program.
Linear responses were noted (R² > 0.998 for APIs, > 0.993 for impurities).
Recovery rates were satisfactory (98-102% for APIs, 90-110% for impurities), meeting precision criteria.