Validation of standard manufacturing procedure of Guḍūcī sattva (aqueous extract of Tinospora cordifolia (Willd.) Miers) and its tablets.

BACKGROUND

Guḍūci Sattva is a highly valued formulation among ayurvedic physicians, commonly recommended in conditions such as Jvara (fever), Dāha (burning sensation) and other conditions of Pitta predominance. In spite of its numerous medicinal attributes, no published work is available until date on manufacturing guidelines along with its quality control parameters.

OBJECTIVE

The aim of this study is to develop the standard manufacturing procedure for preparation of Guḍūci Sattva and its tablets.

METHODS

A total of 15 batches of Guḍūci Sattva were prepared in the laboratory. During its preparation, pharmaceutical findings and observations were systematically recorded. To maintain quality control, Guḍūci Sattva tablets were further subjected to analysis such as shape, diameter, width, hardness, weight variation, disintegration time (DT) and friability. Qualitative analysis to detect the presence of various functional groups and high performance thin layer chromatography (HPTLC) profile were also carried out.

CONCLUSIONS

The average percentage of dried Sattva obtained was 3.8%. The tablets were prepared by direct compression method as per pharmacopoeal specifications. Optimum hardness, weight of tablets, DT and friability of Guḍūci Sattva tablets were found complying with official standards. Alkaloids, carbohydrates and starch were found present in Sattva tablets. Number of peaks obtained in HPTLC also corresponds to this finding. Data obtained by present study may be considered as standard for future studies.

CONCLUSIONS

The average percentage of dried Sattva obtained was 3.8%. The tablets were prepared by direct compression method as per pharmacopoeal specifications. Optimum hardness, weight of tablets, DT and friability of Guḍūci Sattva tablets were found complying with official standards. Alkaloids, carbohydrates and starch were found present in Sattva tablets. Number of peaks obtained in HPTLC also corresponds to this finding. Data obtained by present study may be considered as standard for future studies.