scholarly journals Development and validation of analytical method by HPLC-DAD for determination of vasodilator active in pharmaceutical ophthalmic forms

Author(s):  
Aina Liz Alves Cesar ◽  
Larissa Caldeira Navarro ◽  
Alaíde de Matos Silva ◽  
Rachel Oliveira Castilho ◽  
Gisele Assis Castro Goulart ◽  
...  
Author(s):  
Naira Nayeem Akmal ◽  
Mohd. Imran ◽  
Mohammad Ali Mujtaba

Development of genuine and dependable analytical methods which profile marker phytoconstituents in   an extract containing a mixture of several components is a challenging task. A simple, rapid, precise, and reliable HPLC method was developed for quantification of quercetin from the methanolic extract of Malva neglecta. The estimation was carried out using Phenomenex Gemini-NX-5 µm C18 .The parameters  considered for validation were accuracy, precision, linearity and robustness. The calibration curve was found to be linear in a concentration range of 20–100 μg/mL.The correlation coefficient was r2=0.9996. The % average recovery of quercetin was found to be in the range of 99.82 to 100.52% which was within the acceptance criterion indicating the accuracy of the method. The results of the robustness study indicated that there is no influence of minor changes. The developed and validated method can be successfully used for the determination of quercetin in Malva neglecta; thereby helping in authentication and quality control of this plant.


Author(s):  
Sukhpreet Kaur ◽  
Indu Bala ◽  
Anjoo Kamboj

Objective: To validate simple analytical method and its application in the determination of residual aripiprazole in production area equipment and to confirm the efficiency of cleaning procedure.Methods: The swab sampling and UV method for residual estimation of aripiprazole in swab samples from equipment surfaces after manufacturing of three consecutive batches of aripiprazole 10 mg uncoated tablets were developed and validated.Results: The swab sampling method was developed and validated in order to obtain the suitable recovery (>90%). The swabs were saturated with acetonitrile. The UV method was developed using UV-Vis spectrophotometer at 255 nm. The calibration curve was linear (r2 =1.0000) over a concentration range of 1-30 µg/ml. The LOD and LOQ were 0.43 µg/ml and 1.32µg/ml, respectively. No interference from swab solution was observed and samples were stable for 24h. The determined concentration varying from 1.00-5.687µg/swab was well below the calculated limit of contamination i.e., 24.2µg/swab or 24.2 µg/25 cm2.Conclusion: The results obtained from cleaning procedure confirmed that the proposed procedure was able to remove aripiprazole from equipment surfaces below the value of 10 ppm criteria. So the proposed validated UV method with appropriate swab wipe procedure could be applicable for cleaning validation on residues of aripiprazole.


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