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Analytical Method Development and Validation for Simultaneous Estimation of Cobicistat and Elvitegravir by Using RP-HPLC in Pure and Pharmaceutical Dosage Forms


Affiliations
1 School of Pharmacy, Jawaharlal Nehru Technological University, Kakinada, India
2 School of Pharmaceutical Sciences and Technologies, JNTU Kakinada, India
     

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A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of Cobicistat and Elvetigravir in pharmaceutical Tablet dosage form. The mobile phase consisted of 75:25 % (v/v) of Methanol and 0.1% v/v orthophosphoric acid operated on isocratic mode. The flow rate is 1.0 ml/min. Chromatographic separation of Cobicistat and Elvetigravir was performed on Agilent Zorbax C18 column (150 X 4.6 mm id, ODS 2.5μm). The wavelength of detection is 265 nm. The injection volume is 20μL. The retention time of Cobicistat and Elvetigravir are 2.13 ± 0.02 minutes and 3.87 ± 0.02 min respectively. The run time of analysis is 6 minutes. The developed method was validated for parameters such as accuracy, precision, linearity, limit of detection, limit of quantitation and specificity. The influences of acid, alkaline, oxidative Stress and photolytic stress conditions on both the drugs were studied. Results indicated complete degradation in alkaline medium for Cobicistat and Elvetigravir. The proposed method has been successfully used for the estimation in tablet dosage forms.

Keywords

Cobicistat (COB), Elvitegravir (ELVT), RP-HPLC, OPA (Ortho Phosphoric Acid).
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  • Sharma BK. Instrumental methods of chemical analysis, Introduction to Analytical chemistry, 23th ed. Goel Publishing House Meerut, 2004, 12-23.
  • H.H. Willard, L.L. Merritt, J.A. Dean, F.A. Settle. Instrumental Methods of Analysis, 7th ed., CBS publishers and Distributors, New Delhi. 1986.
  • John Adamovies. Chromatographic Analysis of Pharmaceutical, Marcel Dekker Inc. II Ed New York.
  • Gurdeep Chatwal, Sahm K. Anand. Instrumental methods of Chemical Analysis, 5th edition, Himalaya publishing house, New Delhi, 2002, 1.1-1.8, 2.566-2.570
  • D. A. Skoog. J. Holler, T.A. Nieman. Principle of Instrumental Analysis, 5th edition, Saunders College Publishing, 1998, 778787.
  • Skoog, Holler, Nieman. Principals of Instrumental Analysis,5thEd ition, Harcourt Publishers International Company, 2001.
  • WWW.drugbank.ca/drug/DB01129.
  • WWW.drugbank.ca/drug/DB08810.
  • ICH harmonised tripartite guideline Validation of analytical procedures: text and methodology Q2 (R1).
  • Ch. M. M. Prasada Rao, et al. RP-HPLC method of simultaneous estimation of amlodipine besylate and metoprolol in combined dosage form. 9(2); 2010:69-76.
  • Ch. M. M. Prasada Rao et al. Development and validation of RPHPLC method for Estimation of formoterol fumarate and budesonide in Pressurised meter dose inhaler form. Journal of Applied Science and Research,3 (1);2015: 42-51.

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  • Analytical Method Development and Validation for Simultaneous Estimation of Cobicistat and Elvitegravir by Using RP-HPLC in Pure and Pharmaceutical Dosage Forms

Abstract Views: 334  |  PDF Views: 0

Authors

Vegesna Swetha
School of Pharmacy, Jawaharlal Nehru Technological University, Kakinada, India
S. V. U. M. Prasad
School of Pharmaceutical Sciences and Technologies, JNTU Kakinada, India
Y. Asha Rani
School of Pharmacy, Jawaharlal Nehru Technological University, Kakinada, India

Abstract


A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of Cobicistat and Elvetigravir in pharmaceutical Tablet dosage form. The mobile phase consisted of 75:25 % (v/v) of Methanol and 0.1% v/v orthophosphoric acid operated on isocratic mode. The flow rate is 1.0 ml/min. Chromatographic separation of Cobicistat and Elvetigravir was performed on Agilent Zorbax C18 column (150 X 4.6 mm id, ODS 2.5μm). The wavelength of detection is 265 nm. The injection volume is 20μL. The retention time of Cobicistat and Elvetigravir are 2.13 ± 0.02 minutes and 3.87 ± 0.02 min respectively. The run time of analysis is 6 minutes. The developed method was validated for parameters such as accuracy, precision, linearity, limit of detection, limit of quantitation and specificity. The influences of acid, alkaline, oxidative Stress and photolytic stress conditions on both the drugs were studied. Results indicated complete degradation in alkaline medium for Cobicistat and Elvetigravir. The proposed method has been successfully used for the estimation in tablet dosage forms.

Keywords


Cobicistat (COB), Elvitegravir (ELVT), RP-HPLC, OPA (Ortho Phosphoric Acid).

References