Abstract

PHOTOSTABILITY EVALUATION OF A UNANI FORMULATION SUFOOFE SAILAN

Seema Rani*, Khaleequr Rahman, Mohd. Younis, Sadiya Noorul Basar

Abstract

Photostability study is an important component of stability study ofpharmaceutical products as the loss of potency of the product may bethe result of drug photodecomposition and drug product becomestherapeutically inactive. Adverse effects due to the formation of minordegradation products during storage and administration have beenreported. Thus a well-designed photostability studies ensure the qualityof the product throughout its shelf-life and guarantee its safety,efficacy, and acceptability to the patient. In present studyphotostability of a Unani formulation sufoofe sailan (SS) a polyherbalpowder preparation was carried out. Test drug contains gule dhawa,gule fofal, mochras, gond molsri and suagr and used in Unanimedicine to treat gynaecological diseases. Test drug was prepared in house and evaluated forbase line charactors by physico chemical parameters, HPTLC analysis and microbiologicalanalysis. For photo challenge test drug was packed in two air tight PET container as the drugis available in market and kept in stability chamber. One pack was exposed to overallillumination of 1.2 million lux hours and UV energy of 200 watt hours/square meter. Anotherpack was exposed to 2.4 million lux hours with UV energy of 400 watt hours/square meter.During the study stability chamber was run at 40±2ºC and relative humidity at 75±5%.Physico chemical parameters tested do not show more than 5% change, densitometricHPTLC analysis showed minimum changes, microbiological analysis i.e. total bacterialcount, total fungal count was under the limit set by WHO and specific pathogens were absent.As the physico-chemical changes were less than 5%, and microbial count was within limitsmentioned by WHO guideline, SS confirmed to the ICH Guideline for photostability testingof pharmaceutical product.

Keywords: Photostability study; Sufoofe sailan; UV light; Fluorescent light.