Development And Validation Of A Simple Hplc Method For Estimation Of Mycophenolate Mofetil In Microemulsion Formulation
Int J Pharm Pharm Sci
;
2020 Apr; 12(4): 12-15
Artículo
| IMSEAR
| ID: sea-206073
ABSTRACT
Objective:
The present study deals with the development, validation and application of a simple, precise and accurate HPLC method for the determination of mycophenolate mofetil in pharmaceutical formulations and microemulsions.Methods:
In this method, a simple isocratic mobile phase composition of methanol and water (7525 v/v) pumped at 1 ml/minute flow rate through Phenomenex C18 column (dimension 250 4.6 mm and 5 µm particle size) was used. Injection volume was 20 µl and analysis of mycophenolate mofetil was carried out at 250 nm.Results:
The coefficient of regression was found to be 0.9996, indicating the linearity of the developed method within a range of 0.1 to 10 µg/ml. The limit of detection (LOD) and the limit of quantization (LOQ) were found to be 3.660ng/ml and 11.091ng/ml, respectively. The results showed that % deviation for change in compositions of the mobile phase, flow rate and temperature was within a range of-5.51 to 10.99%,-3.70 to 8.80% and-5.29 to 10.90%, respectively. The method seemed sensitive to change of temperature (±5 ○C) and methanol composition (±2%) as the results were at the boundary limit of 10% deviation.Conclusion:
A simple, precise and accurate HPLC method for the determination of drug content from microemulsion has been developed and validated in accordance with ICH guidelines.
Texto completo:
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Índice:
IMSEAR (Asia Sudoriental)
Revista:
Int J Pharm Pharm Sci
Año:
2020
Tipo del documento:
Artículo
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