DEVELOPMENT AND VALIDATION OF RP-HPLC METHODS FOR DETERMINATION OF MARKERS IN POLYHERBAL FORMULATION NBIOTIC PREMIX

Kotagiri Ravikanth, Anirudh Sharma, Deepak Thakur* and Sameer Sapra

ABSTRACT

Objective: The objective is standardization of herbal formulation “Nbiotic Premix” a natural growth promoter, by using reverse phase high performance liquid chromatography (RP-HPLC). Materials and Methods: RP-HPLC methods were prepared for the standardization of the Nbiotic Premix with respect to the biomarker compounds 6-gingerol and Thymol. The developed methods were validated in accordance with the statistical method of validation given in ICHQ2R1. Results: Developed methods were being successfully applied in identification and quantification of the phytoconstituents. The average recovery of the 6-gingerol (96.57%) and thymol (96.61 %) were computed from regression equation. RSD for inter day and intraday were also found to be less than 2.0 %. Conclusion: The present findings concluded that the RP-HPLC methods developed for standardization of formulation was found to be precise, simple, specific and accurate and can be used for the quality control of formulation and herbs used.

Keywords: Nbiotic Premix, Natural growth promoter, Thymol, 6-gingerol, RP-HPLC, Standardization.