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Design of Experimental approach for the quantification of Bictegravir, content by dissolution method in Tablets formulation using RP-HPLC method
Corresponding Author(s) : Budda Ruthu Salomi
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 12 No. 4 (2024): 2024 Volume -12 - Issue 4
Abstract
In the current study the effort has been undertaken to improve most simple, economical, and sensitive and correct analytical HPLC method for the immediate valuation of these drugs without their prior separation. The method gives resolution with a short analysis time (< 25 min). The method parameter was validated and establishes to be simple, sensitive, accurate and precise. Percentage of recovery shows that the method is free from interference of the excipients used in the formulation. All the three ingredients were effectively resolved and quantified. The developed method reported herein was validated by parameters agreeing to ICH-Q2B guidelines. The offered method provided good system suitability, resolution, precision, accuracy, LOD and LOQ, linearity and robustness and requires less expensive reagents. The procedure designated now is simple, rapid, sensitive, selective and cost effective. It is apparent from the results that the suggested procedure is well suited for dissolution and assay and evaluation of drug, in dosage forms
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- https://www.poz.com/article/fda-approves gileads-singletablet-hiv-regimen-Biktarvy® .
- https://aidsinfo.nih.gov/drugs/589/Bi ktarvy® /203/professional
- https://www.gilead.com/- /media/files/pdfs/medicines/hiv/Biktarvy® /Biktarvy® _pi.pdf?la=en
- Kumar et.al. Development and Validation of Novel Colorimetric method for estimation of Emtricitabine. Indian J of Pharmaceutical Sci. 2016; 78(6): 775-779.
- Mali and More. RP HPLC Method for simultaneous estimation of Impurities from Emtricitabine and Tenofovir disproxil fumarate Tablet. Indian J of Pharmaceutical Sci and Research. 2016; 7(4): 1662-1669.
- Jampala, et al. Development and Application of Liquid Chromatographic Method for Simultaneous Determination of Elvitegravir, Tenofovir Disoproxil Fumarate, Emtricitabine and cobicistat in Fixed Dosage Form. Pharm Methods. 2014; 5(1): 7-13.
- Sunitha, Ilango. Validated HPLC method for the Simultaneous Estimation of Emtricitabine and Tenofovir in drug formulation. Indian J of Pharmaceutical Sci and Research. 2015; 6(6):2418-2422.
- 8. Rao et.al. A Novel Stability Indicating RP-HPLC Method Develoment and Validation for the Determination of Tenofovir Disoproxil Fumarate and Emtricitabine in bulk and pharmaceutical formulation. Indian J Pharmaceutical Sci and Research. 2017; 8(5): 2168-2176. 9
- R.K.Gummalauri et.al. Simultaneous Method for Determination of Emtricitabine and Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Tablets by HPLC . Indian J of Pharmaceutical Sci and Research. 2016; 78(4):532-537
References
https://www.poz.com/article/fda-approves gileads-singletablet-hiv-regimen-Biktarvy® .
https://aidsinfo.nih.gov/drugs/589/Bi ktarvy® /203/professional
https://www.gilead.com/- /media/files/pdfs/medicines/hiv/Biktarvy® /Biktarvy® _pi.pdf?la=en
Kumar et.al. Development and Validation of Novel Colorimetric method for estimation of Emtricitabine. Indian J of Pharmaceutical Sci. 2016; 78(6): 775-779.
Mali and More. RP HPLC Method for simultaneous estimation of Impurities from Emtricitabine and Tenofovir disproxil fumarate Tablet. Indian J of Pharmaceutical Sci and Research. 2016; 7(4): 1662-1669.
Jampala, et al. Development and Application of Liquid Chromatographic Method for Simultaneous Determination of Elvitegravir, Tenofovir Disoproxil Fumarate, Emtricitabine and cobicistat in Fixed Dosage Form. Pharm Methods. 2014; 5(1): 7-13.
Sunitha, Ilango. Validated HPLC method for the Simultaneous Estimation of Emtricitabine and Tenofovir in drug formulation. Indian J of Pharmaceutical Sci and Research. 2015; 6(6):2418-2422.
8. Rao et.al. A Novel Stability Indicating RP-HPLC Method Develoment and Validation for the Determination of Tenofovir Disoproxil Fumarate and Emtricitabine in bulk and pharmaceutical formulation. Indian J Pharmaceutical Sci and Research. 2017; 8(5): 2168-2176. 9
R.K.Gummalauri et.al. Simultaneous Method for Determination of Emtricitabine and Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Tablets by HPLC . Indian J of Pharmaceutical Sci and Research. 2016; 78(4):532-537