Simple, Highly Sensitive Micro HPLC Method for the Determination of Coenzyme Q10 and its Major Related Substances

Abstract

A simiple, rapid, and highly sensitive fast microbore HPLC method with UV detection has been developed for the quantitation of coenzyme Q10 (Co-Q10) and related substances in raw material, pharmaceutical, and cosmetic formulations using a column with hybrid particles. Chromatographic conditions were: 30ºC column temperature, 1 µL injection volume at 275 nm. The Co-Q10 analysis was performed within 2.5 minutes with a flow rate of 0.3 mL/min. with a mobile phase consisted of 100% methanol, and the related substances were separated with a gradient elution based on methanol-water. The developed method was validated for selectivity, linearity, precision, accuracy, and robutness. The method was found to be suitable for the quality control of Co-Q10 in pharmaceutical and cosmetic products, as well as the stability indicating studies.

Keywords:

• Coenzyme Q10
• Fast microbore column
• Pharmaceutical analysis
• Related substances
• UV detection

ACKNOWLEDGMENT

The authors wish to thank Instituto de Investigaciones Cardiologicas Dr.Taquini for providing the HPLC equipment and Dr Jorge Muse for assistance.

Notes

^a According to USP 29 (15)

^b Between Co-Q0 and DU

^c between DU and Co-Q9

^d between Co-Q9 and UB

^e between UB and Co-Q10.

^a Recovery mean values obtained from three individual samples on three different days.

RSD values in parenthesis.

^a Upper and lower case letter represent high and low level of the variable, respectively.

Experimental design according to reference 17.

^a Critical statistic (Ec = tc_(p=0.05) √2 SD).

^a Results are expressed as mean values (n = 3), RSD values in parenthesis.