Validation of UV- Spectrophotometric Method with Stress Degradation study for Gallic acid in Ayurvedic Formulation of Amla Capsule

About author
Vallapudas Hima*, Rubesh Kumar. S, Duganath. N, Devanna. N
Department of Pharmaceutical Analysis,
JNTUA – Oil Technological Research Institute,Anantapur, Andhra Pradesh, India
E-mail: [email protected]

Abstract
Phyllanthus Emblica, commonly known as amla used in the ayurvedic preparations of Indian system of medicine. As there are no reported methods for this ayurvedic capsule dosage form of amla, so in this present study, an attempt has been made to develop an analytical method in spectroscopy for the estimation of gallic acid in this formulation. Spectrophotometric estimation of ascorbic acid shows the maximum absorbance at 274nm.  Beer’s law is obeyed in the concentration range of 1-6 μg/ml. Assay method was developed for the ayurvedic formulation, the percentage purity was found to be 99.19 % w/v.  The method was validated as per ICH guidelines and results were statistically calculated. Recovery studies were carried out and the percentage recovery was found to be 99.32 -100.11%w/v, the system was found to be linear and the correlation coefficient (r²) was found to be 0.9999, method was found to be precise and the relative standard deviation for intraday and interday was found to be 1.12 and 0.99 respectively, detection and quantification limit was found to be 0.1201μg/ml and 0.3642μg/ml respectively. The stress degradation studies were performed for both API and Ayurvedic formulation as per ICH guidelines, the degradation was observed in oxidative, photolytic, hydrolytic degradation under acidic, alkaline conditions and dry heat induced studies.
Keywords: Gallic acid, Spectrophotometry, Stress degradation studies.
Introduction
Amla (syn: Emblica officinalis, Emblica Myrobalan, Phyllanthus Emblica) also known as Indian gooseberry. It is a deciduous tree of the family belong to family Euphorbiaceae  and this species is native to India and also grows in tropical and subtropical regions including Pakistan, Srilanka, South East Asia, China and Malaysia. The fruits of Emblica officinalis are widely used in the Ayurveda and are believed to defense against diseases. Different types of gooseberry species are present world widely, those are  Pereskia aculeate  (syn: Barbados gooseberry) belongs to family Cactaceae and it  is native to tropical America, Physalis peruviana (syn: cape goose berry ) belongs to family Solanaceae and it is  native to South Africa, Dovyalis hebecarpa (syn: Ceylon gooseberry) belongs to family  Flacourtiaceae and it is native to Sri Lanka and southern India, Kiwifruit  (syn: Chinese goose berry) belongs to family Actinidiaceace and it  is native to New Zealand, Italy, Chile, Greece and france^’, Phyllanthus acidus (syn: star gooseberry) belongs to family  Phyllanthaceae and it is  native to South East Asian countries, Ribes grossularia (syn: European berry)  belongs to family Grossulariaceae and it is native to Europe east to the Caucasus and south to North Africa, Ribes hirtellum(syn: American goose berry) belongs to family Melastomaceae and it is  native to Northern America.Emblica officinalis primarily contains tannins (gallic acid, ellagic acid), 1-O-galloyl-beta-D-glucose, 3,6-di-O-galloyl-Dglucose, chebulinic acid, quercetin, alkaloids, phenolic compounds, amino acids and carbohydrates, chebulagic acid. Its fruit juice contains the highest vitamin C. Gallic acid is a phenolic compound exists in plant material in the form of free acids, esters, catechin derivatives and hydrolysable tannins. The interest in this compound is due to its pharmacological activity as radical scavengers. It has been proved to have potential preventive and therapeutic effects in many diseases, where the oxidative stress has been implicated, including cardiovascular diseases, antioxidant, antimicrobial, antiviral, anticarcinogenic, radio protective neurodegenerative disorders and anti purgative.