METHOD VALIDATION FOR DETERMINATION OF SILDENAFIL CITRATE IN EXTEMPORANEOUS ORAL SUSPENSION
作者： Apichart Atipairin , Chuthamas Woradechakul , Somchai Sawatdee , Attawadee Sae Yoon , Kridsada Sae Chee
DOI:
关键词: Chemistry 、 Uv detection 、 Chromatography 、 Retention time 、 Ammonium acetate 、 Detection limit 、 Forced degradation 、 Suspension (vehicle) 、 High-performance liquid chromatography 、 Sildenafil
摘要: Objective: The aim of this study was to validate a high-performance liquid chromatographic (HPLC) method for analysis sildenafil citrate in an extemporaneous preparation, according ASEAN guideline the validation analytical procedure. Methods: condition used C18 column with mobile phase consisted 50% 0.2 M ammonium acetate buffer pH 7.0 and acetonitrile. flow rate performed at 1.0 mL/min, UV detection monitored 245 nm. Results: It shown that retention time about 8.80 min. specific presence other common excipients preparation. accurate (100.18% recovery), precise (< 2% RSD), robust. Linear correlation obtained over concentration range 0.01 - 60.00 mg/mL (r 2 = 0.9999). Limit (LOD) limit quantification (LOQ) were 3.82 11.57 ng/mL, respectively. Forced degradation showed would serve as stability-indicating procedure applied drug stability studies. Conclusion: proposed met general requirements acceptable performance validation. reliable, served method. Therefore, it can be determine suspension preparation . Keywords: Sildenafil Citrate, HPLC, Validation, Extemporaneous, Suspension.
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