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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 of
pharmaceutical products as the loss of potency of the product may be
the result of drug photodecomposition and drug product becomes
therapeutically inactive. Adverse effects due to the formation of minor
degradation products during storage and administration have been
reported. Thus a well-designed photostability studies ensure the quality
of the product throughout its shelf-life and guarantee its safety,
efficacy, and acceptability to the patient. In present study
photostability of a Unani formulation sufoofe sailan (SS) a polyherbal
powder preparation was carried out. Test drug contains gule dhawa,
gule fofal, mochras, gond molsri and suagr and used in Unani
medicine to treat gynaecological diseases. Test drug was prepared in house and evaluated for
base line charactors by physico chemical parameters, HPTLC analysis and microbiological
analysis. For photo challenge test drug was packed in two air tight PET container as the drug
is available in market and kept in stability chamber. One pack was exposed to overall
illumination of 1.2 million lux hours and UV energy of 200 watt hours/square meter. Another
pack 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, densitometric
HPTLC analysis showed minimum changes, microbiological analysis i.e. total bacterial
count, 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 limits
mentioned by WHO guideline, SS confirmed to the ICH Guideline for photostability testing
of pharmaceutical product.

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


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