Research Journal of Pharmacy and Technology

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UV Spectrophotometric Method for the Determination of Sirolimus in Bulk and its Dosage Form


Affiliations
1 Department of Pharmaceutical Analysis, University College of Pharmaceutical Science, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur – 522510, Andhra Pradesh, India
     

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Objective: The main objective was to develop and validate the UV-Spectrophotometric method for the estimation of Sirolimus in bulk and pharmaceutical formulations as per ICH guidelines. Materials and methods: A simple, rapid, accurate, and economical UV-spectrophotometric method has been developed for the estimation of Sirolimus from bulk and pharmaceutical formulation. Results: The λmax of Sirolimus in Dimethyl Sulfoxide was found to be 274 nm. The drug follows linearity in the concentration range 3–21 μg/ml with a correlation coefficient value of 0.9956. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated was 101.35%. and was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 75%, 100%, and 125%. The % recovery was found to be in the range of 99.30– 101.03%. The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intraday; interday variations, and repeatability. The % RSD value < 2 indicates that the method is precise. Conclusion: The above method was a rapid tool for routine analysis of sirolimus in the bulk and in the pharmaceutical dosage form.

Keywords

Sirolimus, Dimethyl Sulfoxide, UV, Validation.
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  • UV Spectrophotometric Method for the Determination of Sirolimus in Bulk and its Dosage Form

Abstract Views: 239  |  PDF Views: 0

Authors

S. K. Mastanamma
Department of Pharmaceutical Analysis, University College of Pharmaceutical Science, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur – 522510, Andhra Pradesh, India
S. K. Reehana
Department of Pharmaceutical Analysis, University College of Pharmaceutical Science, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur – 522510, Andhra Pradesh, India
L. Prudhvi
Department of Pharmaceutical Analysis, University College of Pharmaceutical Science, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur – 522510, Andhra Pradesh, India
Ravi Kiran
Department of Pharmaceutical Analysis, University College of Pharmaceutical Science, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur – 522510, Andhra Pradesh, India

Abstract


Objective: The main objective was to develop and validate the UV-Spectrophotometric method for the estimation of Sirolimus in bulk and pharmaceutical formulations as per ICH guidelines. Materials and methods: A simple, rapid, accurate, and economical UV-spectrophotometric method has been developed for the estimation of Sirolimus from bulk and pharmaceutical formulation. Results: The λmax of Sirolimus in Dimethyl Sulfoxide was found to be 274 nm. The drug follows linearity in the concentration range 3–21 μg/ml with a correlation coefficient value of 0.9956. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated was 101.35%. and was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 75%, 100%, and 125%. The % recovery was found to be in the range of 99.30– 101.03%. The low values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intraday; interday variations, and repeatability. The % RSD value < 2 indicates that the method is precise. Conclusion: The above method was a rapid tool for routine analysis of sirolimus in the bulk and in the pharmaceutical dosage form.

Keywords


Sirolimus, Dimethyl Sulfoxide, UV, Validation.

References