Method development and validation of raltegravir by RP-HPLC method

Authors

  • Shirisha Bhavani Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M),Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • A. Srinivasa Rao Department of Pharmacy Practice, Bhaskar Pharmacy College, Yenkapally, Moinabad (M), Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • B. Sharone Aneeta Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M),Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • G. Sumanth Reddy Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M),Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • Mohd Azhaniddin Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M),Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • B. Basanth Reddy Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M),Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA
  • T.Arun Department of Pharmaceutical Analysis, Bhaskar Pharmacy College, Yenkapally, Moinabad (M),Ranga Reddy (Dt), Hyderabad – 500 075, Telangana, INDIA

DOI:

https://doi.org/10.61096/ijpar.v8.iss3.2019.320-328

Keywords:

Raltegravir, HPLC, Method Development, ICH, Validation, Accuracy, Precision.

Abstract

Objective

The objective of the present research work was to develop an innovative, simple, and economic method for estimation of Raltegravir in bulk and dosage form by RP-HPLC.

Methods

The chromatographic conditions were performed on Symmetry Develosil ODS HG-5 RP C18, 5mm, 15cmx4.6mm i.d. as stationary phase and mobile phase was prepared with a mixture of Phosphate buffer (pH=3.0) : Methanol with 30:70,  flow 1.0 ml/min, with Injection Volume 10µl, at detection wavelength 246 nm and run time at 5.0 min.

Results

The analytical method is valid for estimation of Raltegravir over a range of 20 µg/ml–70 µg/ml. The results of system suitability test, linearity, precision and accuracy, robustness, specificity, LOD and LOQ and stabilities presented in this report are within the acceptance range.

Conclusion

A specific, sensitive, economic method estimation of Raltegravir has been developed based on ICH Guidelines with bulk and dosage forms.

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Published

2022-09-12

How to Cite

Shirisha Bhavani, A. Srinivasa Rao, B. Sharone Aneeta, G. Sumanth Reddy, Mohd Azhaniddin, B. Basanth Reddy, & T.Arun. (2022). Method development and validation of raltegravir by RP-HPLC method. IJPAR JOURNAL, 8(3), 320–328. https://doi.org/10.61096/ijpar.v8.iss3.2019.320-328

Issue

Vol. 8 No. 3 (2019): 2019 Volume - 8 Issue - 3

Section

Articles