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

  • 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

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.

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

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KAUR, P., M. KUMAR, and U. K. MANDAL. “DEVELOPMENT AND VALIDATION OF A SIMPLE HPLC METHOD FOR ESTIMATION OF MYCOPHENOLATE MOFETIL IN MICROEMULSION FORMULATION”. International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 12, no. 4, Mar. 2020, pp. 16-20, doi:10.22159/ijpps.2020v12i4.36750.
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