scholarly journals Liquid Chromatographic Method for Determination of Nisoldipine from Pharmaceutical Samples

2010 ◽  
Vol 7 (3) ◽  
pp. 751-756 ◽  
Author(s):  
Amit Gupta ◽  
Ram S. Gaud ◽  
S. Ganga
Keyword(s):  
High Performance ◽  
Chromatographic Method ◽  
Peak Height ◽  
Peak Height Ratio ◽  
Height Ratio ◽  
Liquid Chromatographic Method ◽  
Aluminum Plates ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple and specific high performance thin layer chromatographic method was developed and validated for the determination of nisoldipine from tablet dosage form. The method was carried out at 320 nm after extraction of drug in methanol. The method uses aluminum plates pre-coated with silica gel 60F-254 as stationary phase and cyclohexane-ethyl acetate-toluene (3:3:4, v/v/v) as mobile phase. Linearity was established over a range of 400-2400 ng per zone. Both peak area ratio and peak height ratio showed acceptable correlation coefficienti.e.more than 0.99. However we used peak area for validation purpose. Intra-day and inter-day precision was determined and found to have less than 6.0 % RSD.

scholarly journals DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF DAPAGLIFLOZIN AND ITS IMPURITIES IN TABLET DOSAGE FORM

2019 ◽  
pp. 447-453
Author(s):  
CAROLINE GRACE A ◽  
PRABHA T ◽  
SIVAKUMAR T
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Good Precision ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: The aim of the present work is the development of new, sensitive, specific, and accurate high-performance liquid chromatographic method for the separation and determination of dapagliflozin and its impurities in tablet dosage form. Methods: The chromatographic separation of drug and its impurities was achieved using Hypersil BDS C18 column (250 mm × 4.6 mm, 5 μ) with mobile phase consisted of mobile phase-A (Buffer pH 6.5) and mobile phase-B (acetonitrile:water 90:10) by gradient program at a flow rate of 1 mL/min with ultraviolet detection at 245 nm. Results: Dapagliflozin and its impurities A, B, C, D, E, and impurity-F were successfully eluted at the retention time of 16.95, 2.72, 7.82, 10.58, 21.11, 30.37, and 34.36 min, respectively, with good resolution. The method was validated according to the international conference on harmonization guidelines. The validation results showed good precision, accuracy, linearity, specificity, sensitivity, and robustness. Conclusion: Successful separation and determination of dapagliflozin and its six impurities were achieved by the proposed method. The developed method can be applied for the routine analysis of dapagliflozin and its impurities in pharmaceutical formulations.

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