Introduction.

The development of an analytical method requires standardization and adjusting of parameters tests to ensure its correct operation. Furthermore, validation of the method is also essential to guarantee specificity, sensitivity and precisión of the quality of the pharmaceutical products. This study presents an innovative method using High Performance Liquid Chromatography (HPLC), for the simultaneous detection of Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Caffeine and Ascorbic acid in oral powder. This protocol is the first validated method in Bolivia for this purpose.

Objective.

To develop and valídate an analytical method for the simultaneous Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Caffeine and Ascorbic acid detection in oral powder using HPLC

Methodology.

HPLC couple to a phenyl column at 30°C was used for the test. Phosphate buffer at pH 3,5 was used for gradient elution and acetonitrile as mobile phase. The detection was performed at wavelength of 202 nm, and the sample injection volume was 10 µL. The validation of the methodology was confirmed in accordance with USP-NF and ICH Q2(R2).

Results.

A total of 14 parameters, including the selection of mobile and stationary phases, chromatographic conditions, high peak resolution and negligible inte rieren ees, were measured for the analytical method. In terms of validation of the method, the linearity (R2 > 0.99) of the method was confirmed statistically by ANOVA (p<0.05). The precisión of the method found coefficients of variation ≤2%. The specificity was validated through the t Student test with valúes of texp<ttab (2,78). Finally, the accuracy was evaluated at three concentration levéis, finding recovery percentages between 8,1% and 100%.

Conclusión.

The validated method forthe simultaneous detection of Acetaminophen, Dextromethorphan hydrobromide, Phenylephrine hydrochloride, Caffeine, and Ascorbic acid in oral powder by HPLC is specific, linear, accurate, precise and can be routinely used for oral powder composition evaluation

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