Jain Pritam¹*, Dhulgunde Snehal² and Nandre Mayur²

¹Department of Pharmaceutical Analysis, R. C. Patel Institute of Pharmaceutical Education and Research, Maharashtra, India
²M. Pharm. Student, R. C. Patel Institute of Pharmaceutical Education and Research, (M.S.), India

*Corresponding Author: Jain Pritam, Associate Professor, Department of Pharmaceutical Analysis, R. C. Patel Institute of Pharmaceutical Education and Research, Maharashtra, India.

Received: April 06, 2023; Published: August 04, 2023

Abstract

A simple, rapid, accurate and sensitive UV-spectrophotometric method has been developed for estimation of Pimecrolimus from bulk and pharmaceutical cream formulation. The method based on the sulfuric acid reaction and the λ_max of Pimecrolimus in acetonirile was found to be 360 nm. The drug follows linearity in the concentration range 10-60 µg/ml with correlation coefficient value 0.9978. The proposed method was applied to pharmaceutical cream formulation and % amount of drug estimated 98.16% was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120%. The % recovery was found to be in the range 98.54%– 99.69%. The low values of % R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The % R.S.D. value less than 2 indicate that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. For routine analyses of pimecrolimus in bulk and in pharmaceutical dosage form, the mentioned procedure was rapid and employed as a quality-control tool.

 Keywords: Pimecrolimus; UV; Validation; Quantitative Determination

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Citation

Citation: Jain Pritam., et al. “Development and Validation of UV-Spectrophotometric Method for Determination of Pimecrolimus in Bulk and in Cream Formulation". Acta Scientific Pharmaceutical Sciences 7.9 (2023): 11-16.

Copyright

Copyright: © 2023 Jain Pritam., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.