Development and Validation of New Analytical Method for The Simultaneous Estimation of Darunavir And Ritonavir in Pharmaceutical Dosage Form
Abstract
A simple, Accurate, precise method was developed for the simultaneous estimation of the Darunavir and Ritonavir in Tablet dosage form. The chromatogram was run through Agilent C18 150 x 4.6 mm, 5m. Mobile phase containing Buffer 0.1% Formic acid: Acetonitrile, taken in the ratio 70:30 was pumped through the column at a flow rate of 0.95 ml/min. The temperature was maintained at 30°C. The optimized wavelength selected was 293 nm. The retention times of Darunavir and Ritonavir were found to be 2.369min and 2.911. %RSD of the Darunavir and Ritonavir were and found to be 0.7 and 0.5 respectively. %Recovery was obtained as 99.67% and 99.78% for Darunavir and Ritonavir respectively. LOD, LOQ values obtained from regression equations of Darunavir and Ritonavir were 1.49, 5.191and 0.37, 1.11 respectively. Regression equation of Darunavir is y = 5421x + 640.7, and y = 3870.x + 5191 of Ritonavir. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control tests in Industries.
Keywords:
Darunavir, Ritonavir, RP-HPLC
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References
https://www.chemsrc.com/en/cas/635728-49-3_1170683.html
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB0119429.htm
Peter John, Waqar Azeem, Muhammad Ashfaq, Islam Ullah Khan, Syed Naeem Razzaq and Salah Ud-Din Khan. StabilityIndicating RP-HPLC method for Simultaneous Determination of Methoxsalen and p-aminobenzoic acid in binary combination. 2015; 29 (1), 27-39.
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Ravindra B Nehete and Pushpendra Sharma. Analytical Method Validation: Planning and its significance. Journal of Harmonized Research in Applied Science. 2017; 5(4), 172-177.
Kala Shweta and Singh Anita. A Review on Analytical Method Validation. International Journal of Pharma Research and Review. 2016; 5(9), 30-36.
Tulsi Modi, Bhumi Patel and Jaimin Patel. Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lignocaine HCl and Nlfedipine in cream. Journal of Pharmaceutical Analysis, 2016; 5(1), 1-37.
Manisha b Mane, Pranali j Gaikawad, Anuja v Patil . RP-HPLC method for determination of darunavir in bulk and pharmaceutical preparations. International Journal of Pharmaceutical Science Review and Research. 2013; 21(2), 20-23.
G.Raveendra babu, Lakshmana rao and J. Venkateswara rao. Development and validation of novel HPLC method for estimation of darunavir in pharmaceutical formulations, International Journal of Research in Pharmacy and Chemistry. 2013; 3(2), 2231-2781.
Nagendrakumar AVD, Sreenivasa Rao B and Basaveswara Rao MV. Validated RP - HPLC Method for the Determination of Darunavir in Bulk and Pharmaceutical Formulation. Research Journal of Pharmaceutical, Biological and Chemical Sciences, 2014; 5(3), 63-74.
Santosh V. Gandhi and Rasika R. Korhale. A RP-HPLC Method Development and Validation for the Estimation of Ritonavir in Bulk and Pharmaceutical Dosage Form, Journal of Chemical and Pharmaceutical Research. 2016; 8(7), 901-904.
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Sigamala S. Kumar, Donthireddy Sai Priyanka and Paul Richards M. RPHPLC Method Development and Validation for Simultaneous Estimation of Cobicistat and Darunavir in Tablet Dosage Form. World Journal of Pharmacy and Pharmaceutical Sciences. 2016; 5 (6), 490-499.
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C.Varaprasad and K.Ramakrishna. Simultaneous Quantification of Atazanavir and Ritonavir in Pharmaceutical Dosage Form by Validated RP-HPLC Method. International Journal of Pharmacy & Pharmaceutical Research. 2015; 3 (4), 26-37.
Alagar Raja. M, Bhavana, Rao. K N V. Simultaneous Estimation of Method Development and Validation of Atazanavir and Ritonavir by RPHPLC Method. Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2015; 3(3), 89 - 99.
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Tulsidas mishra and Pranav S. Shrivastav. Validation of Simultaneous Quantitative Method of HIV protease inhibitors Atazanavir, Darunavir and Ritonavir in human plasma by UPLC-MS/MS. The Scientific World Journal. 2014; 3(2), 1-13.
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Rao CM, Konda R, Ramanjeneeyulu S. Estimation of Nevirapine Anhydrous Bulk Formulation by Using IR, RP-HPLC, GC Methods. Research Journal of Pharmacy and Technology. 2010 Dec 28;3(4):1088-92.
Ch M M Prasada et al, Development and Validation of a Novel Stability Indicating RP-HPLC Method for The Estimation of Entecavir In Tablet Formulation, EJBPS, 2017, 4(7):176-180
Kumaraswamy.Gandla, R.Lalitha, Dara Varun Kumar, and P.VR Teja Shruthi. “Analytical Method Development & Validation for the Simultaneous Estimation of Ledipasvir and Sofosbuvir in Bulk and it’s Dosage Form by Rp-Hplc”. International Journal of Pharmaceutics and Drug Analysis, Apr. 2020, pp. 6-15,
Z. M. Sayyed, Aijaz A. Sheikh, Zakirhussain A. Shaikh, S. A. Shinde, . J. Chaware5, and K. R. Biyani. “DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF TENO-FOVIR AND EMTRICITABINE IN PHARMACEUTICAL DOSAGE FORMS BY HPLC”. International Journal of Pharmaceutics and Drug Analysis, Jan. 2016, pp. 24-29,
Gokul S. Sanap, Nilesh S. Zarekar, and Sarita S. Pawar. “REVIEW ON METHOD DEVELOPMENT AND VALIDATION”. International Journal of Pharmaceutics and Drug Analysis, May 2017, pp. 177-84,
K, V. G., T. K, and S. P. P. “A New Stability Indicating Analytical Method Development And Validation for The Quantitative Determination of Emitricitabine And Lamivudine By RP-HPLC”. World Journal of Current Medical and Pharmaceutical Research, Vol. 2, no. 2, May 2020, pp. 184-90, doi:10.37022/WJCMPR.2020.2219.
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB0119429.htm
Peter John, Waqar Azeem, Muhammad Ashfaq, Islam Ullah Khan, Syed Naeem Razzaq and Salah Ud-Din Khan. StabilityIndicating RP-HPLC method for Simultaneous Determination of Methoxsalen and p-aminobenzoic acid in binary combination. 2015; 29 (1), 27-39.
ICH, Validation of Analytical Procedures; Methodology, Q2 (R1), International Conference on Harmonization, IFPMA, Geneva, 1996.
ICH Q1A (R2) Guidelines, Stability testing of new drug substances and products, 2003.
Ravindra B Nehete and Pushpendra Sharma. Analytical Method Validation: Planning and its significance. Journal of Harmonized Research in Applied Science. 2017; 5(4), 172-177.
Kala Shweta and Singh Anita. A Review on Analytical Method Validation. International Journal of Pharma Research and Review. 2016; 5(9), 30-36.
Tulsi Modi, Bhumi Patel and Jaimin Patel. Development and Validation of Stability Indicating RP-HPLC Method for Simultaneous Estimation of Lignocaine HCl and Nlfedipine in cream. Journal of Pharmaceutical Analysis, 2016; 5(1), 1-37.
Manisha b Mane, Pranali j Gaikawad, Anuja v Patil . RP-HPLC method for determination of darunavir in bulk and pharmaceutical preparations. International Journal of Pharmaceutical Science Review and Research. 2013; 21(2), 20-23.
G.Raveendra babu, Lakshmana rao and J. Venkateswara rao. Development and validation of novel HPLC method for estimation of darunavir in pharmaceutical formulations, International Journal of Research in Pharmacy and Chemistry. 2013; 3(2), 2231-2781.
Nagendrakumar AVD, Sreenivasa Rao B and Basaveswara Rao MV. Validated RP - HPLC Method for the Determination of Darunavir in Bulk and Pharmaceutical Formulation. Research Journal of Pharmaceutical, Biological and Chemical Sciences, 2014; 5(3), 63-74.
Santosh V. Gandhi and Rasika R. Korhale. A RP-HPLC Method Development and Validation for the Estimation of Ritonavir in Bulk and Pharmaceutical Dosage Form, Journal of Chemical and Pharmaceutical Research. 2016; 8(7), 901-904.
Zakir Ahmad Sandeep s. sonawane Atharva s. bhalerao. Development of a validated RP-HPLC method for estimation of Darunarvir in spiked Human Plasma with UV Detection. International Research Journal of Pharmacy. 2016; 7(1), 24-28.
J. Sathish kumar reddy, k. R. S. Prasad and k. Suresh babu. AStability Indicating RP-HPLC method for Simultaneous Estimation of Darunavir and Cobicistat in bulk and Tablet Dosage Form. Der Pharmacia Lettre. 2016; 8 (12), 89- 96.
Sigamala S. Kumar, Donthireddy Sai Priyanka and Paul Richards M. RPHPLC Method Development and Validation for Simultaneous Estimation of Cobicistat and Darunavir in Tablet Dosage Form. World Journal of Pharmacy and Pharmaceutical Sciences. 2016; 5 (6), 490-499.
Venkateswara Rao B, Vidyadhara S and Ram Babu. R, Analytical Method Development and Validation for Simultaneous Estimation of Lopinavir and Ritonavir by RPHPLC. International Journal of Research & Development in Pharmacy & Life Science.2014; 3 (4), 1074-1079.
C.Varaprasad and K.Ramakrishna. Simultaneous Quantification of Atazanavir and Ritonavir in Pharmaceutical Dosage Form by Validated RP-HPLC Method. International Journal of Pharmacy & Pharmaceutical Research. 2015; 3 (4), 26-37.
Alagar Raja. M, Bhavana, Rao. K N V. Simultaneous Estimation of Method Development and Validation of Atazanavir and Ritonavir by RPHPLC Method. Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2015; 3(3), 89 - 99.
T Sankarshana and Md. Musthafa. RP-HPLC Method Development & Validation for Simultaneous Estimation of Cobicistat and Dorunavir in Bulk and Pharmaceutical Dosage Form. International Journal of Medical Sciences & Pharma Research. 2017; 3(2), 13-22.
Tulsidas mishra and Pranav S. Shrivastav. Validation of Simultaneous Quantitative Method of HIV protease inhibitors Atazanavir, Darunavir and Ritonavir in human plasma by UPLC-MS/MS. The Scientific World Journal. 2014; 3(2), 1-13.
Rao CP, Rahaman SA, Prasad YR, Reddy PG. RP-HPLC method of simultaneous estimation of amlodipine besylate and metoprolol in combined dosage form. International Journal of Pharmaceutical Research and Development. 2010 Nov;2(9):69-76.
Rao CM, Konda R, Ramanjeneeyulu S. Estimation of Nevirapine Anhydrous Bulk Formulation by Using IR, RP-HPLC, GC Methods. Research Journal of Pharmacy and Technology. 2010 Dec 28;3(4):1088-92.
Ch M M Prasada et al, Development and Validation of a Novel Stability Indicating RP-HPLC Method for The Estimation of Entecavir In Tablet Formulation, EJBPS, 2017, 4(7):176-180
Kumaraswamy.Gandla, R.Lalitha, Dara Varun Kumar, and P.VR Teja Shruthi. “Analytical Method Development & Validation for the Simultaneous Estimation of Ledipasvir and Sofosbuvir in Bulk and it’s Dosage Form by Rp-Hplc”. International Journal of Pharmaceutics and Drug Analysis, Apr. 2020, pp. 6-15,
Z. M. Sayyed, Aijaz A. Sheikh, Zakirhussain A. Shaikh, S. A. Shinde, . J. Chaware5, and K. R. Biyani. “DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR SIMULTANEOUS ESTIMATION OF TENO-FOVIR AND EMTRICITABINE IN PHARMACEUTICAL DOSAGE FORMS BY HPLC”. International Journal of Pharmaceutics and Drug Analysis, Jan. 2016, pp. 24-29,
Gokul S. Sanap, Nilesh S. Zarekar, and Sarita S. Pawar. “REVIEW ON METHOD DEVELOPMENT AND VALIDATION”. International Journal of Pharmaceutics and Drug Analysis, May 2017, pp. 177-84,
K, V. G., T. K, and S. P. P. “A New Stability Indicating Analytical Method Development And Validation for The Quantitative Determination of Emitricitabine And Lamivudine By RP-HPLC”. World Journal of Current Medical and Pharmaceutical Research, Vol. 2, no. 2, May 2020, pp. 184-90, doi:10.37022/WJCMPR.2020.2219.
Published
29/04/2021
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Pemra Raju, K. Thejomoorthy, and P.Sreenivasa Prasanna, “Development and Validation of New Analytical Method for The Simultaneous Estimation of Darunavir And Ritonavir in Pharmaceutical Dosage Form”, Int J Indig Herb Drug, pp. 49-57, Apr. 2021.
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