STABILITY INDICATING HPLC METHOD FOR PARACETAMOL, CAFFEINE, PHENYLEPHRINE HCL, CHLORPHENAMINE MALEATE AND ITS IMPURITIES IN FLUCOLD TABLET DOSAGE FORM

Paracetamol, caffeine, phenylephrine, and chlorphenamine maleate are available on the market to treat pains, psychoactive disorders, and bronchopulmonary disorders. The objective was to develop a single HPLC method to determine paracetamol, caffeine, phenylephrine HCl, chlorphenamine maleate, and its impurities in flu cold tablets combination dosage form. No analytical method is available to assess the quality of flu cold tablets’ combination dosage form; hence the present research was taken. The evaluated method was validated with Inert sustain C18 AQ  250 mm x4.6 mm, 3µm column, flow rate of  0.7 mL/min, 220 nm wavelength, 50 µL injection volume, 35 °C column temperature and gradient program run time 160 min and also used the pH 2.5 and 4.0 phosphate buffer. This single method was developed and validated with precision, accuracy, ruggedness, linearity, robustness, and specificity by following ICH and USP validation of compendial procedures. The degradation study was performed at all stress conditions such as water hydrolysis, acid hydrolysis, base hydrolysis, oxidation, thermal and light exposure, the peak purity of each active pharmaceutical ingredient in combination dosage form less than peak threshold, which indicates that developed and validated HPLC method was stability-indicating.