• Mr. Vishal Kumar Pathak
• Prof. Phool Chandra
• Prof. Bhupendar Singh

Abstract Objective: A HPLC Method development and Validation by using QbD Tools/Approach for Coenzyme Q10 and its Combination. Purpose: In Coenzyme Q10, Q refers to the quinine chemical group and 10 refer to the number of isoprenyl chemical subunit in its tail. In general ubiquinones, the number can be anywhere from 6 to 10. It is very important part of the Electron Transport Chain and participates in aerobic cellular respiration, which produces energy in the form of ATP. A study reported that 95% of the Human body’s energy is produced this way. Therefore, those organs with the higher energy requirements- such as the liver, heart and kidney- have the highest CoQ10 concentrations. Coenzyme Q10 (CoQ10) is a fat soluble, vitamin-like naturally occurring substance. The purpose of this research is to evaluate the recently published evidence on the development and validation of HPLC methods for Coenzyme Q10 using the QbD approach. While a few QbD-based stability-indicating RP-HPLC methods for Coenzyme Q10 have been reported, there are no QbD-based spectroscopic methods or QbD-based methods for Coenzyme Q10 in combination with other drugs. Therefore, it is worth considering the development of a QbD-based analytical method for Coenzyme Q10, both alone and in combination with clomiphene citrate, and applying this method to analyze its research or marketed formulations. Furthermore, a PSAR study indicates that no QbD-based analytical method has been patented for Coenzyme Q10, either alone or in combination with other drugs.

Keywords: - Coenzyme Q10 (CoQ10), RP-HPLC, Analytical QbD, Patent Search Analysis Research (PSAR )

"A Research Review on “APPLICATION OF NOVEL QBD APPROACH IN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ANALYSIS OF COENZYME Q10 IN SINGLE AND COMBINED DOSAGE FORMS”", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 3, page no.i394-i404, March-2025, Available :http://www.jetir.org/papers/JETIR2503856.pdf

"A Research Review on “APPLICATION OF NOVEL QBD APPROACH IN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ANALYSIS OF COENZYME Q10 IN SINGLE AND COMBINED DOSAGE FORMS”", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 3, page no. ppi394-i404, March-2025, Available at : http://www.jetir.org/papers/JETIR2503856.pdf