DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR ANALYSIS OF LERCANIDIPINE IN BULK DRUG AND MICROEMULSION FORMULATION

2012 ◽  
Vol 36 (1) ◽  
pp. 143-154 ◽  
Author(s):  
Nitin Parmar ◽  
Neelam Singla ◽  
Saima Amin ◽  
Kanchan Kohli
Keyword(s):  
Hplc Method ◽  
Microemulsion Formulation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug ◽  
Development And Validation

Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Voriconazole in Bulk Drug

2010 ◽  
Vol 3 (2) ◽  
pp. 978-986
Author(s):  
Wamorkar V V ◽  
C S Ramaa ◽  
Manjunath S Y ◽  
V Malla Reddy
Keyword(s):  
Mobile Phase ◽  
Hplc Method ◽  
Good Resolution ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation ◽  
Different Levels

RP-HPLC method has been developed and validated for the determination of voricaonazole in bulk drug. The developed method is found to be specific, reproducible, and stability indicating. The Hypersil, C18 (250 X 4.6 mm) 5μ column was used and mobile phase consisting of water:acetonitrile to achieve good resolution and retention of the analyte and its impurities. The detector linearity was established from concentrations ranging from 5-100 μg/ml. The method was tested at different levels of specificity and accuracy as per requirements given in ICH guidelines. The molecule was exposed to the stress conditions such as acid, base, oxidation, heat and light as per the recommendations of ICH guidelines. The method was proved to be robust with respect to changes in flow rate, mobile phase composition and allied columns. The proposed method is found to be sensitive, precise, rapid, reproducible, and offers good column life.

scholarly journals Forced Degradation of Flibanserin Bulk Drug: Development and Validation of Stability Indicating RP-HPLC Method

2022 ◽  
Vol 56 (1) ◽  
pp. 32-42
Author(s):  
Yik-Ling Chew ◽  
Hon-Kent Lee ◽  
Mei-Ann Khor ◽  
Kai-Bin Liew ◽  
Bontha Venkata Subrahmanya Lokesh ◽  
...  
Keyword(s):  
Drug Development ◽  
Hplc Method ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Rp Hplc ◽  
Bulk Drug ◽  
Development And Validation
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