DEVELOPMENT AND VALIDATION OF A SIMPLE HPLC METHOD FOR ESTIMATION OF MYCOPHENOLATE MOFETIL IN MICROEMULSION FORMULATION

PALAKDEEP  KAUR; MOHIT  KUMAR; UTTAM KUMAR  MANDAL

doi:10.22159/ijpps.2020v12i4.36750

Authors

PALAKDEEP KAUR Department of Pharmaceutical Sciences and Technology, Maharaja Ranjit Singh Punjab Technical University (MRSPTU), Badal Road, Bathinda, Punjab 151001, India
MOHIT KUMAR Department of Pharmaceutical Sciences and Technology, Maharaja Ranjit Singh Punjab Technical University (MRSPTU), Badal Road, Bathinda, Punjab 151001, India
UTTAM KUMAR MANDAL Department of Pharmaceutical Sciences and Technology, Maharaja Ranjit Singh Punjab Technical University (MRSPTU), Badal Road, Bathinda, Punjab 151001, India

DOI:

https://doi.org/10.22159/ijpps.2020v12i4.36750

Keywords:

Mycophenolate Mofetil, High-performance liquid chromatography (HPLC), Validation, Psoriasis, Microemulsion

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 (75:25 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.

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