Abstract

ENHANCING QUALITY CONTROL OF GOLDEG®: BIOMARKER STANDARDIZATION FOR A PHYTOGENIC EGG-LAYING STIMULANT USING VALIDATED ISOCRATIC RP-HPLC

Anirudh Sharma, Pushap Lata and Deepak Thakur*

ABSTRACT

Achieving and sustaining optimal egg production levels is crucial for the success of a poultry layer enterprise. However, egg production in layers is often influenced by multiple factors, including endocrine or nutritional depletion, poor management practices, and various diseases. To address these challenges, Goldeg®, a phytogenic egg-laying stimulant marketed by M/s Zenex Animal Health India Private Limited, has been formulated to help enhance and restore optimal production levels in layers. To ensure the safety, efficacy, and quality control of this formulation, a standardization protocol has been incorporated into the present study. As part of this protocol, two key biomarkers—piperine and 6-gingerol—were analyzed using reliable, specific, and highly sensitive quality control methods. For their quantification, reverse-phase high-performance liquid chromatography (RP-HPLC) equipped with a photodiode array detector (PDA) was employed, ensuring precise identification and measurement of thesebioactive compounds within the herbal formulation. The retention time values recorded for piperine (10.02±0.012 minutes) and 6-gingerol (8.35±0.011 minutes) in both the Goldeg® formulation and reference standards were found to be comparable under UV light at 345 nm and 280 nm, respectively. Furthermore, the percentage concentrations of piperine and 6-gingerol in the Goldeg® formulation were determined to be 0.062±0.0120% w/w and 0.022±0.0087% w/w, respectively. Bioactive markers such as piperine and 6-gingerol serve as distinctive indicators of specific ingredients or botanicals, facilitating the identification and verification of their presence in herbal formulations. The quantification of these biomarkers using high-performance liquid chromatography (HPLC) is widely regarded as the most effective method for assessing and standardizing herbal formulations. By employing this approach, the present study establishes a robust framework for ensuring the quality control of Goldeg® throughout its development and production process, thereby reinforcing its reliability and consistency as an egg-laying stimulant for poultry layers.

Keywords: Poultry, Egg, Egg-laying stimulant, Safety, Acute oral toxicity, Goldeg®