Asian Journal of Pharmaceutical Analysis

S. Kathirvel ¹, R. Raju ¹, B. Seethadevi ², A. Suneetha ³, K. Jyothisree ³

Affiliations
1 Department of Pharmaceutical Analysis, National College of Pharmacy, Manassery, Kozhikode, Kerala, 673602, IN
2 Department of Pharmacognosy, National College of Pharmacy, Manassery, Kozhikode, Kerala, 673602, IN
3 Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi road, Guntur, A.P, 522002, IN

Abstract

The study is a proposition of the application of high performance liquid chromatography (HPLC) with a spectrophotometric UV range detector to analyse the chemical purity and assay of tetrabenazine in bulk drug and tablet formulation and also to apply the proposed method to determine the content uniformity according to USP specification. During computer assisted literature search only a few publications were found about tetrabenazine, so the ultimate objective of the present investigation was aimed to develop stability - indicating LC method and the development of the newer analytical method was achieved under optimised chromatographic conditions by using mobile phase composed of potassium phosphate buffer: acetonitrile in the ratio (40:60v /v). The seperation was achieved by using isocratic elution mode with a flow rate of 1.0 mL/min. The effluent was monitored on a UV detector at 284 nm. The retention time of tetrabenazine was found to be at 5.05min and the standard calibration curve was linear over a concentration range of 6.25-37.5 μg/mL with r value of 0.999. The LOD and LOQ were found to be 0.562 and 1.704 μg/mL respectively. The recovery studies were performed and the percentage recoveries were found to be in the range of 98.64-98.88 %. The drug was also subjected to acidic, basic, oxidative and photolytic degradation as per the ICH guidelines. The developed method allows to separate all degradation from tetrabenazine and to quantitate the tetrabenazine amount. As there is no official monograph in the pharmacopeias about tetrabenazine, the performed full validation procedure makes the method ready to use in routine analysis.

Keywords

Content Uniformity, ICH Guidelines, Tetrabenazine And USP Specification.

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A. Suneetha ¹, K. Manasa ¹

Affiliations
1 Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur, A.P - 522002, IN

Abstract

A simple, sensitive, precise and accurate UV Spectrophotometric method has been developed for estimation of andrographolide in kalmegh plant extract. The method is based on the formation of red-orange colored complex with picric acid in an alkaline medium and obeys beer's law in the range of 10 - 100μg/mL exhibiting the maximum absorbance at 481nm. The limit of detection and quantification were found to be 1.0μg/mL and 3.0μg/mL, respectively. The calibration curve demonstrated a linear relationship between the absorbance and concentration, with the correlation coefficient 0.9998. The Regression equation of the curve was Y=0.0114x + 0.0067. The method was validated according to ICH guidelines.

Keywords

Andrographolide, Picric Acid, NaOH, Validation, ICH Guidelines.

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