STABILITY INDICATING HPLC METHOD FOR PARACETAMOL, CAFFEINE, PHENYLEPHRINE HCL, CHLORPHENAMINE MALEATE AND ITS IMPURITIES IN FLUCOLD TABLET DOSAGE FORMAbstract
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.
Ganpisetti Srinivasa Rao *, D. Rama Devi, P. Sunil Reddy, L. Kalyanaraman, Parimalkumar Sureshbhai Patel, B. Venkata Subbaiah, B. M. Rao, Nagaraju Rajana and K. Basavaiah
Department of Chemistry, Visakhapatnam, Andhra Pradesh, India.
11 January 2021
22 August 2021
12 October 2021
01 December 2021