STANDARDIZATION OF HERBAL MULTIACTION SKIN FORMULATION NEWCHARM® GEL THROUGH VALIDATED GAS CHROMATOGRAPHY AND ISOCRATIC RP-HPLC

Anirudh Sharma, Pushap Lata* and Deepak Thakur

ABSTRACT

Ensuring the authenticity, safety, and effectiveness of herbal medicines is unquestionably a paramount concern for the industry. Presently, the prevailing quality control framework predominantly centers on chemical markers, primarily focusing on the proper accurate utilization of raw materials and addressing safety concerns. Validated gas chromatography (GC) and reverse-phase high-performance liquid chromatography (HPLC) methods were established with flame ionization (FID) and photo-diode array detection (PDA), respectively, to quantify the levels of 1,8-cineole and β-asarone. These compounds are found within a complex natural matrix in the ayurvedic medicine NEWCHARM® GEL. Effective chromatographic separation of 1,8-cineole and β-asarone was achieved using a Shimadzu SH-Rxi-5Sil MS 30m x 0.25mm x 0.25μm gas chromatography capillary column and a Phenomenex Luna5μ (RP C18, 25cm × 4.6mm × 100A°) liquid chromatography column. The GC-FID and RP-HPLC-PDA methodologies proposed here underwent thorough statistical validation, encompassing assessments of linearity, range, precision, accuracy, selectivity, and robustness. The calibration curves displayed remarkable linearity within specified ranges: 25.0–125.0μg/mL for 1,8-cineole and 15.0-120.0μg/mL for β-asarone, each exhibiting correlation coefficients exceeding 0.998. In the case of the chromatographic analysis approach, its application to the herbal formulation NEWCHARM® GEL resulted in the successful quantification of phytoconstituents, accompanied by excellent recovery values, and notably, no interfering peaks stemming from the excipients were observed. The viability and significance of this methodology for verifying bioactive markers introduce new, exceedingly sensitive, and reliable approaches for standardizing herbal formulations containing 1,8-cineole and β-asarone.

Keywords: 1,8-cineole, ?-asarone, Chromatography, GC-FID, NEWCHARM® GEL, RP-HPLC-PDA.