| Submission to first decision
(The average time from manuscript submission to desk rejection, direct rejection/acceptance or assignment to the first editor) Note: For manuscripts that fully comply with the journal template. However, this timeframe does not apply to manuscripts with formatting or guideline deficiencies. If a manuscript is returned to the authors for corrections, the administrative review process will restart from the re-submission date. |
3 weeks |
|---|---|
| Submission to decision after review (For papers that are sent to review, the average time from submission to receipt of first editor decision) | 6 weeks |
| Submission to final decision (The average time from manuscript submission to the final editorial decision) | 16 weeks |
| Submission to publication (The average time from acceptance to publication. Manuscript published in early view are also included in this calculation) | 24 weeks |
ACTA Pharmaceutica Sciencia
2017 , Vol 55 , Num 1
Biorelevant and Quality Control Dissolution Method Development and Validation of Quetiapine Fumarate Tablets
1 Department of Quality Assurance, Sultan - Ul -Uloom College of Pharmacy, Road No: 3, Banjara Hills, Hyderabad - 500034, Telangana State, India2 Bojjam Narasimhulu Pharmacy College for Women, Saidabad, Hyderabad - 500059, Telangana State, India
DOI : 10.23893/1307-2080.APS.0552 Viewed : 19322 - Downloaded : 7508 The aim of this study was to develop and validate Biorelevant and Quality control dissolution method for poorly water soluble drug Quetiapine Fumarate (QF). The Ultra Violet spectrophotometric method developed was based on the direct estimation method using 248 nm as λmax. The method was validated according to International Conference on Harmonization (ICH) guidelines which include precision, specificity, accuracy and linearity. The Biorelevant dissolution medium i.e., Blank Fed State Simulated Intestinal Fluid (FeSSIF) and Quality control dissolution medium i.e., 0.1N Hydro Chloric acid were selected on the basis of solubility studies. Stability studies were performed in respective dissolution mediums and the sample solutions were found to be stable for 2 days. The corresponding Biorelevant and Quality control dissolution profiles were constructed and the selected brands showed more than 85% drug release within 20 min. Thus, the proposed Biorelevant and Quality control dissolution methods can be used successfully. Keywords : Biorelevant, Dissolution, Quetiapine fumarate, UV spectrophotometry, Validation