Sonja, Jose (2014) Method Development of Accelerated Stability Study of Adapalene GEL by HPLC in Pharmaceutical Formulations. Masters thesis, C.L. Baid Metha College of Pharmacy, Chennai.
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Abstract
The present study Adapalene gel (0.1%w/w&0.3%w/w) packed in final container (Essel pro –pack) were kept at Accelerated , intermediated and Long- term stability storage condition in stability chamber and samples were drawn at regular intervals based on physical, chemical, biological tests, the analysis reports shows that the product is stable till 6 th month Accelerated stability storage condition. Also the viscosity and consistency studies show that the product is stable. The results is obtained are summarized below. The developed method was validated according to ICH guidelines and all the parameters were within the limits. Conclusion: The stability studies carried out by various stability indicating parameters like Description, identification by HPLC,, pH, Related substances, Water, Assay and preservative content for Adapalenegel(0.1%w/w&0.3%w/w)a3stabilityconditions..Accelerated stability conditions (40ºC±2ºC/75%RH±5%RH) Intermediate stability condition (30ºC±2ºC/65%RH±5%RH) and Long- Term stability condition (25ºC±2ºC/60%RH±5%RH) and compatibility studies. The development method was validated according to ICH guideness and all the parameters were within the limits. All the above tests indicated that the values obtained were well within the limits specified. No changes need to be introduced in formulation manufacturing process and proposed container and closure. Since the study was carried out for 6 months, further study need to be carried out for 9,12,18,24 and 36 months as per the product specification under labelled storage conditions.
| Item Type: | Thesis (Masters) |
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| Uncontrolled Keywords: | Accelerated Stability Study; Adapalene GEL; HPLC; Pharmaceutical Formulations |
| Subjects: | PHARMACY > Pharmaceutical Analysis |
| Depositing User: | Ravindran C |
| Date Deposited: | 20 Oct 2017 05:30 |
| Last Modified: | 20 Oct 2017 05:30 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/3692 |
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