Analytical method cross validation by HPLC for identification of five markers and quantification of one marker in SynacinnTM formulations and its in vivo bone marrow micronucleus test data

Siti Nurazwa Zainol; Anis Fadhlina; Sri Vijaya Rentala; Renuka Pillai; Manjula Yalaka; Indu Bansal; Earati Surender; Leela Krishna Vatsavai; Rajesh Eswarappa; Hassan Fahmi Ismail; Fadzilah Adibah Abdul Majid

doi:10.1016/j.dib.2021.107001

Analytical method cross validation by HPLC for identification of five markers and quantification of one marker in Synacinn^TM formulations and its in vivo bone marrow micronucleus test data

Data Brief. 2021 Apr 8:36:107001. doi: 10.1016/j.dib.2021.107001. eCollection 2021 Jun.

Authors

Affiliations

¹ Proliv Life Sciences Sdn Bhd, D-15, Residensi Bistaria, Jln Ulu Kelang, Taman Ukay Bistari, Ampang, Selangor Darul Ehsan 68000, Malaysia.
² Institute of Marine Biotechnology, Universiti Malaysia Terengganu, Kuala Nerus, Terengganu Darul Iman 21030, Malaysia.
³ Faculty of Pharmacy, International Islamic University Malaysia, Bandar Indera Mahkota, Kuantan, Pahang 25200, Malaysia.
⁴ Aurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Hyderabad, Telangana 500049, India.

Abstract

A HPLC method has been validated for identifying five markers (gallic acid, rosmarinic acid, catechin, andrographolide and curcumin) and quantifying curcumin in Synacinn^TM formulation. The validation (bracketed strengths of 10 mg/mL and 100 mg/mL) involved assessment of selectivity, precision, Limit of Detection (LOD), Limit of Quantification (LOQ), linearity, accuracy, stability in diluent and formulation stability. Meanwhile, in vivo bone marrow micronucleus test data was presented to evaluate the toxicity potential of Synacinn™ to cause clastogenicity and/or disruption of the mitotic apparatus, as measured by its ability to induce micronucleated polychromatic erythrocytes (MN PCE) in Sprague Dawley rat bone marrow. The test was conducted in two phases viz., Phase I (Dose Range Finding experiment) and Phase II (Definitive experiment). Phase I was conducted to assess general toxicity and bone marrow cytotoxicity of Synacinn™, and to select the doses for the definitive experiment. In-life observations included mortality, clinical signs of toxicity and body weight. Bone marrow samples were collected and extracted from the femur bone using fetal bovine serum. The pellet obtained after the centrifugation was used for preparing bone marrow smears to evaluate the number of immature and mature erythrocytes.

Keywords: Bone marrow micronucleus test; Botanical medicine; Clastogenicity; Cross validation; Curcumin; HPLC; SynacinnTM.