A NEW VALIDATED SIMULTANEOUS REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY ASSAY METHOD FOR ESTIMATION OF TWO FLAVONES (BAICALEIN AND CHRYSIN) IN API DRUGS


Maddi Sesharao, Vallabaneni Madhavarao

Abstract


 

 Objective: The scope of the present work is a reversed-phase high-performance liquid chromatography (RP-HPLC) assay method developed for the simultaneous determination of baicalein and Chrysin in API drugs.

Methods: The RP-HPLC method employed a Hypersil BDS C18 reversed-phase column (150×4.6 mm×5.0 μm) with an isocratic mixture of water and acetonitrile in the ratio of 55:45; v/v as the mobile phase. The column temperature was kept at 25°C. The flow rate was 1.0 mL/min, and detection was by means of a photodiode array detector at wavelength of 268 nm and validated for various parameters such as specificity, system suitability, method precision, linearity, accuracy, solution stability, ruggedness, and robustness.

Results: The system suitability parameters were evaluated from standard chromatograms by calculating the % relative standard deviation (RSD) from six replicate injections for baicalein and Chrysin peak areas. The % RSD for the peak area of the principal peak from six replicate injections of each standard solution was <2.0%. The linearity and correlation coefficient of baicalein and Chrysin was found to be 0.999. Method precision was performed, and % RSD from six different preparations for baicalein and Chrysin were found to be <2.0. The % recovery for each level was found to be the range of 98.0–102%. In ruggedness and robustness, the % RSD of the peak area of all peaks for six replicate injections should be not more than 2.0.

Conclusion: Hence, the chromatographic assay method developed for baicalein and chrysin is said to be rapid, simple, specific, sensitive, precise, accurate, and reliable that can be effectively applied for routine analysis in research institutions, quality control department in industries, approved testing laboratories, bio-pharmaceutics, and bio-equivalence studies and in clinical pharmacokinetic studies.


Keywords


Baicalein, Chrysin, Reversed-phase high-performance liquid chromatography, Method development, Validation.

| PDF |

References


Wang F, Xu Z, Ren L, Tsang SY, Xue H. GABA A receptor subtype selectivity underlying selective anxiolytic effect of baicalin. Neuropharmacology 2008;55:1231-7.

Anandhi R, Annadurai T, Anitha TS, Muralidharan AR, Najmunnisha K, Nachiappan V, et al. Antihypercholesterolemic and antioxidative effects of an extract of the oyster mushroom, Pleurotus ostreatus, and its major constituent, chrysin, in triton WR-1339-induced hypercholesterolemic rats. J Physiol Biochem 2013;69:313-23.

ICH, Q2A, Harmonized Tripartite Guideline, Validation of analytical Procedure Methodology. Geneva: IFPMA, Proceedings of the International Conference on Harmonization; 1994.

ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology; 2005.

ICH Q2B, Harmonized Triplicate Guideline. Validation of Analytical Procedure Methodology. Geneva: IFPMA, Proceeding of the International Conference on Harmonization; 1996.

Bhamre PR, Rajput SJ. Development of HPLC and chemometric assisted spectrophotometric method for the simultaneous determination of five active ingradients in cough and cold tablets and their application to dissolution study. Int J Pharm Pharm Sci 2016;l8: ???.

Rajoriya V, Soni A, Kashaw V. Method development and validation of dissolving tablet of ramipril by HPLC method. Int J Pharm Pharm Sci 2016;8:127-31.




About this article

Title

A NEW VALIDATED SIMULTANEOUS REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY ASSAY METHOD FOR ESTIMATION OF TWO FLAVONES (BAICALEIN AND CHRYSIN) IN API DRUGS

Keywords

Baicalein, Chrysin, Reversed-phase high-performance liquid chromatography, Method development, Validation.

DOI

10.22159/ajpcr.2018.v11i1.21174

Date

01-01-2018

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 11 Issue 1 January 2018 Page: 351-356

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

23 Views | 6 Downloads

Authors & Affiliations

Maddi Sesharao
Department of Organic Chemistry, Bapatla Engineering College (Autonomous) Bapatla, Andhra Pradesh, India.
India

Vallabaneni Madhavarao
Department of Organic Chemistry, Bapatla Engineering College (Autonomous) Bapatla, Andhra Pradesh, India.
India


Article Tools


Email this article (Login required)
Email the author (Login required)

Refbacks

  • There are currently no refbacks.