Estimation of molnupiravir in bulk and capsule by Novel RP-HPLC method development and validation

Authors

  • Ravi Kumar Vejandla Department of Pharmacy, St.Mary’s Group of Institutions Hyderabad, Deshmukhi (V),Yadadri-Bhoovanagiri (D), Telangana (State), India.
  • Uzma Begum Department of Pharmacy, St.Mary’s Group of Institutions Hyderabad, Deshmukhi (V),Yadadri-Bhoovanagiri (D), Telangana (State), India.
  • Nakerekanti Sandeep Department of Pharmacy, St.Mary’s Group of Institutions Hyderabad, Deshmukhi (V),Yadadri-Bhoovanagiri (D), Telangana (State), India.
  • Pathlavath Ramesh Department of Pharmacy, St.Mary’s Group of Institutions Hyderabad, Deshmukhi (V),Yadadri-Bhoovanagiri (D), Telangana (State), India.
  • Vankdoth Venkatesh Department of Pharmacy, St.Mary’s Group of Institutions Hyderabad, Deshmukhi (V),Yadadri-Bhoovanagiri (D), Telangana (State), India.
  • Talagapu Ujwala Department of Pharmacy, St.Mary’s Group of Institutions Hyderabad, Deshmukhi (V),Yadadri-Bhoovanagiri (D), Telangana (State), India.
  • PannalaSai Kiran Reddy Department of Pharmacy, St.Mary’s Group of Institutions Hyderabad, Deshmukhi (V),Yadadri-Bhoovanagiri (D), Telangana (State), India.

Keywords:

Molnupiravir, RP-HPLC, Method Development, Validation, Accuracy, Robustness

Abstract

Objective: The current investigation was pointed at developing and progressively validating novel, simple, responsive RP-HPLC method for the measurement of active pharmaceutical ingredient and Marketed Pharmaceutical Dosage form of Molnupiravir.

Methods: A simple, selective, validated isocratic RP-HPLC methodology for the quantitative determination of Molnupiravir. The chromatographic strategy utilized Phenomenex Luna ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm, using isocratic elution with a mobile phase of Phosphate Buffer (0.02M) and Acetonitrile were consists of 60:40% v/v (pH-2.80). A flow rate of 1.0 ml/min and a detector wavelength of 246 nm utilizing the UV detector were given in the instrumental settings. Validation of the proposed method was carried out according to an international conference on harmonization (ICH) guidelines.

Results: LOD and LOQ for the two active ingredients were established with respect to test concentration. The calibration charts plotted were linear with a regression coefficient of R2>0.999, means the linearity was within the limit. Recovery, specificity, linearity, accuracy, robustness, ruggedness were determined as a part of method validation and the results were found to be within the acceptable range.

Conclusion: The proposed method to be fast, simple, feasible and affordable in assay condition. During stability tests, it can be used for routine analysis of the selected drug

Published

2024-04-24

Issue

Vol. 12 No. 2 (2024): 2024 Volume -12 - Issue 2

Section

Articles
Copyright & Licensing