Degradation Pathway for Rilpinavir Hydrochloride by Validated Stability Indicating UP-LC Method
Journal Title: International Journal of Clinical Pharmacology & Toxicology(IJCPT) - Year 2012, Vol 1, Issue 1
Abstract
Degradation pathway for Rilpivirine Hydrochoride is established as per ICH recommendations by validated and stability indicating reverse phase liquid chromatographic method. Rilpivirine Hydrochoride is subjected to stress conditions of acid, base, oxidation, thermal and photolysis. Significant degradation is observed in acid and base stress conditions. Six impurities are studied and the major degradant (RRT about 0.52) is identified by LC-MS and spectral analysis. The stress samples are assayed against a qualified reference standard and the mass balance is found close to 99.5 %. Efficient chromatographic separation is achieved on a Shimpack XR –ODS-II stationary phase with simple mobile phase combination delivered in gradient mode and quantification is carried at 295 nm at a flow rate of 1.0 mL min-1.In the developed LC method the resolution between Rilpivirine Hydrochoride and six potential impurities (imp-1, imp-2, imp-3, imp-4, imp-5 and imp-6) is found to be greater than 2.0. Regression analysis shows an r value (correlation coefficient) of greater than 0.995 for Rilpivirine Hydrochoride and six potential impurities. This method is capable to detect the impurities of Rilpivirine Hydrochoride at a level of 0.006% with respect to test concentration of 1.0 mg mL-1 for a 4-µL injection volume. The developed LC method is validated with respect to specificity, linearity & range, accuracy, precision and robustness for impurities and degradant determination.
Authors and Affiliations
Mohanreddy Chilukuri
Keywords
Related Articles
- EP ID EP201592
- DOI 10.19070/2167-910X-120001
- Views 110
- Downloads 0
Phenytoin Induced Cerebellar Ataxia and Orofacial Dyskinesia in a Case of Disseminated Cysticercosis: A Case Report
We report a 25 year old male patient who developed phenytoin induced cerebellar ataxia and orofacial dyskinesias that resolved after discontinuation of phenytoin. This patient also had disseminated cysticercosis, i.e. di...
Underdiagnosed Paraquat Induced Pneumothorax and Pneumomediastinum, The “Daisley Barton Syndrome”: A Clinical Feature Of Paraquat-Induced Acute Lung Injury
The incidence of paraquat ingestion for self-harm, occurs at an alarming rate in Trinidad and Tobago W.I and is virtually synonymous with acute multi-organ failure and death in most settings. Yet recognition of pneumotho...
Degradation Pathway for Rilpinavir Hydrochloride by Validated Stability Indicating UP-LC Method
Degradation pathway for Rilpivirine Hydrochoride is established as per ICH recommendations by validated and stability indicating reverse phase liquid chromatographic method. Rilpivirine Hydrochoride is subjected to stres...
28-Homocastasterone: A Novel Plant Ketosteroid Enhances Tissue Transaminase Catalytic Activity and Gene Expression in Normal and Diabetic Male albino wistar Rat
28-Homocastasterone (28-HC) is a brassinosteroid family phytohormone. Humans were exposed through diet and herbal based folk medicine, although its mammalian cellular influence unknown. Present study investigated 28-HC c...
Clinical Evaluation of Deferasirox For Removal of Cr+6 Ions In Rats
The present research aimed to characterize the potential efficiency of deferasirox in removing chromium after its administration for 60 days following two doses of 15 and 30 mg/kg Cr+6 to the body weight of the male Wist...