摘要

Ocimum sanctum is well known for its wide range of therapeutic activities. In this article, a methodology to define the safety of the herb with its chromatographic fingerprint has been established. We report the fingerprint method for three standardized extracts of O. sanctum and the correlation of the chromatographic peaks with their in vivo pharmacological safety profile. HPLC fingerprints with the statistical similarity correlation were validated and used in acute and sub-acute toxicity studies in Charles Foster rats. Under optimized chromatographic conditions, numbers of constituents of O. sanctum were successfully separated by the reverse-phase HPLC methods. Various groups have been marked in the chemical fingerprint. The effects on body weight and biochemical indices were mainly related to the chromatographic peaks of group II and V. On the basis of characteristic UV spectra, it was observed that the peaks of group II were related with phenolic moieties. Further, the peak number 11 of group II was characterized as rosmarinic acid-a naturally occurring polyphenolic compound with antioxidant and anti-inflammatory properties by reference comparison. All three extracts in both acute and sub-acute toxicity experiments were well tolerated, and no adverse changes were observed in mortality, morbidity, gross pathology, body weight, and biochemical parameters. This accurate and reproducible method can be used for the chemical identification in standardized extract of O. sanctum leaves, batch-to-batch quality assurance, adulteration, and their safety evaluation.