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

A HPLC method has been validated for identifying five markers (gallic acid, rosmarinic acid, catechin, andrographolide and curcumin) and quantifying curcumin in SynacinnTM formulation. The validation (bracketed strengths of 10 mg/mL and 100 mg/mL) involved assessment of selectivity, precision, Limit...

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Main Authors: 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
Format: Article
Language:English
Published: Elsevier 2021-06-01
Series:Data in Brief
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2352340921002857
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spelling doaj-c37882a4917c4cbc98aeeac952fc31422021-06-27T04:37:53ZengElsevierData in Brief2352-34092021-06-0136107001Analytical 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 dataSiti Nurazwa Zainol0Anis Fadhlina1Sri Vijaya Rentala2Renuka Pillai3Manjula Yalaka4Indu Bansal5Earati Surender6Leela Krishna Vatsavai7Rajesh Eswarappa8Hassan Fahmi Ismail9Fadzilah Adibah Abdul Majid10Proliv Life Sciences Sdn Bhd, D-15, Residensi Bistaria, Jln Ulu Kelang, Taman Ukay Bistari, Ampang, Selangor Darul Ehsan 68000, MalaysiaInstitute of Marine Biotechnology, Universiti Malaysia Terengganu, Kuala Nerus, Terengganu Darul Iman 21030, Malaysia; Faculty of Pharmacy, International Islamic University Malaysia, Bandar Indera Mahkota, Kuantan, Pahang 25200, MalaysiaAurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Hyderabad, Telangana 500049, IndiaAurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Hyderabad, Telangana 500049, IndiaAurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Hyderabad, Telangana 500049, IndiaAurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Hyderabad, Telangana 500049, IndiaAurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Hyderabad, Telangana 500049, IndiaAurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Hyderabad, Telangana 500049, IndiaAurigene Pharmaceutical Services Limited, Bollaram Road, Miyapur, Hyderabad, Telangana 500049, IndiaInstitute of Marine Biotechnology, Universiti Malaysia Terengganu, Kuala Nerus, Terengganu Darul Iman 21030, MalaysiaProliv Life Sciences Sdn Bhd, D-15, Residensi Bistaria, Jln Ulu Kelang, Taman Ukay Bistari, Ampang, Selangor Darul Ehsan 68000, Malaysia; Institute of Marine Biotechnology, Universiti Malaysia Terengganu, Kuala Nerus, Terengganu Darul Iman 21030, Malaysia; Corresponding author.A HPLC method has been validated for identifying five markers (gallic acid, rosmarinic acid, catechin, andrographolide and curcumin) and quantifying curcumin in SynacinnTM 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.http://www.sciencedirect.com/science/article/pii/S2352340921002857Botanical medicineSynacinnTMCurcuminCross validationHPLCClastogenicity
collection DOAJ
language English
format Article
sources DOAJ
author 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
spellingShingle 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
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
Data in Brief
Botanical medicine
SynacinnTM
Curcumin
Cross validation
HPLC
Clastogenicity
author_facet 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
author_sort Siti Nurazwa Zainol
title 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
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
publisher Elsevier
series Data in Brief
issn 2352-3409
publishDate 2021-06-01
description A HPLC method has been validated for identifying five markers (gallic acid, rosmarinic acid, catechin, andrographolide and curcumin) and quantifying curcumin in SynacinnTM 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.
topic Botanical medicine
SynacinnTM
Curcumin
Cross validation
HPLC
Clastogenicity
url http://www.sciencedirect.com/science/article/pii/S2352340921002857
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