Development of standard operating procedures and quality standard of Kushta Gaodanti with HPTLC fingerprinting and hyphenated techniques

Abstract

Kushta Goadanti is a compound Unani formulation, prescribed in Unani System of Medicine for therapeutic actions, such as Daf-e-Tap (Antipyretic), Mohallil-e-Waram (Anti-inflammatory) and therapeutic used such as In Waja-ul-Mafasil (Arthralgia), Niqras (Gout) and Irq-un-Nisa (Sciatica) has been taken up for standardization by modern hyphenated techniques, so as to ascertain its quality standards. In the present study, Kushta Gaodanti was prepared by classical methods and standardization, was carried out in the premises of Department of Ilmul Advia and approved by the Institutional Ethical Committee (NTC/A/16/101), Government Nizamia Tibbi College, Hyderabad and the modern hyphenated techniques were studied in the laboratory of CSIR-IICT (DW 0560), Tarnaka. In this study, Kushtae Gaodanti was prepared by three methods. The Kushta Gaodanti prepared was analyzed through organoleptic properties, preliminary tests and physicochemical parameters, HPTLC fingerprint study along with hyphenated techniques such as XRD studies for the metal analysis in the samples. Moreover, elements and heavy metals were also estimated in all the three samples of Kushta Gaodanti. The data and results obtained in the study are thoroughly described in the paper. The parameters such as physico-chemical parameters, high performance thin layer chromatography (HPTLC) and XRD studies which are carried out, revealed as the specific identity for the drug under study and to establish as a pharmacopoeial standards. Results suggested that the drug is safe for therapeutic use and its batch-to-batch identification and determination of quality can be checked using the present study as reference standard in future.