A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral dosage form

Kokkirala, Tej Kumar; Prasad, KDV; Alegete, Pallavi; Suryakala, Duvvuri

doi:10.1002/bmc.5121

Cited by 4 publications

(4 citation statements)

References 18 publications

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“…The literature search reveals that various analytical techniques have been employed for the quantification of DOR (Doravirine), TDF (Tenofovir disoproxil fumarate), and LMV (Lamivudine), both in combination and individually. Some of the widely used methods include high-performance liquid chromatography (HPLC) and ultraperformance liquid chromatography (UPLC), which have been referenced in several studies [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16]. Additionally, a high-pressure thin-layer chromatography (HPTLC) method has been reported for the quantification of LMV and TDF alone and in combination [17][18][19][20][21][22][23][24][25][26].…”

Section: Robustnessmentioning

confidence: 99%

“…Previous literature searches revealed that various other analytical techniques, such as high-performance liquid chromatography (HPLC) [2][3][4][5][6][7][8][9][10][11][12][13], ultra-performance liquid chromatography (UPLC) [14][15][16], have been employed for the quantification of DOR, TDF, and LMV in combination and alone. High-pressure thin layer chromatography (HPTLC) [17][18][19][20][21][22][23][24][25][26] method has been reported for quantification alone and in combination with LMV and TDF.…”

Section: Introductionmentioning

confidence: 99%

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HPTLC Method for Simultaneous Estimation of Lamivudine, Tenofovir Disoproxil Fumarate, and Doravirine

DAMLE,

KHAIRNAR

2023

Int J Pharm Pharm Sci

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Objective: The objective of this study was to develop and validate an HPTLC method for the simultaneous estimation of Lamivudine, Tenofovir disoproxil fumarate, and doravirine. The method is aimed to provide reliable and efficient quantification of these drugs. Methods: The chromatographic separation of drugs was performed on aluminum plates coated with silica gel 60 F254. Samples were spotted on the plate as a 6 mm wide band using a linomat applicator and a 100 µl syringe. The mobile phase used was a mixture of ethyl acetate, methanol, and chloroform (07:02:01 % v/v/v). Densitometric scanning at 226 nm was conducted using a Deuterium lamp as the radiation source, and the data were analyzed using win CATS software. The method was validated following the ICH Guideline ICH Q2 (R1). Results: The optimized method lead to the resolution of drugs with the Rf values of doravirine (0.75±0.02), Tenofovir disoproxil fumarate (0.57±0.02), and lamivudine (0.37±0.02). Doravirine exhibited a linear range of 500-1500 ng/band with a favorable linear equation and regression coefficient of 0.999. Tenofovir disoproxil fumarate and lamivudine showed a linear range of 1500-4500 ng/band, and both compounds displayed a linear relationship with a regression coefficient of 0.997. The method's accuracy was assessed through recovery studies, and the LOD and LOQ were determined for each drug. Conclusion: The optimized HPTLC method was validated in this study, following the ICH Q2 (R1) guidelines, it demonstrates its efficacy for the quantitative analysis of Doravirine, Tenofovir disoproxil fumarate, and lamivudine. The method offers reliable quantification of these compounds in a combined dosage form and can be used for routine analysis in pharmaceuticals.

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Section: Robustnessmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

HPTLC Method for Simultaneous Estimation of Lamivudine, Tenofovir Disoproxil Fumarate, and Doravirine

DAMLE,

KHAIRNAR

2023

Int J Pharm Pharm Sci

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“…As per the literature, it was known that very few analytical methods were identified for doravirine in pharmaceutical formulations such as UV spectroscopic method (Shalin et al, 2011), RP-HPLC methods (Suneetha et al, 2021;Hanuman et al, 2020;Ahamed et al, 2022), UPLC (Tandrima and Shivakumar, 2022) and LC-MS/MS (Ming et al, 2016;Zang and Yang, 2016;Desai et al, 2019). There are some analytical methods that are developed in combination with other drugs (Kokkirala et al, 2021;Godela and Gummadi, 2021;Gollu and Gummadi, 2020). Nonetheless, it became apparent that there was only one UV spectrophotometric method available for assessing doravirine in pharmaceutical formulations.…”

Section: Introductionmentioning

confidence: 99%

Creation and validation of a UV spectrophotometric method for the measurement of doravirine in both raw material and pharmaceutical compositions

Gorja,

Preetham,

Marepally

et al. 2023

J. Phytonanotech. Pharmaceut. Sci.

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A straightforward, specific, accurate, precise, and highly sensitive UV spectrophotometric technique was designed and validated for quantifying the drug doravirine in both its pure forms and also in pharmaceutical formulations. The entire method relies on measuring the compound's absorbance at 314 nm using methanol as the solvent. The final linearity of this method spans a concentration range of 1-10 ppm, and it exhibits strong linear correlations with a highest correlation coefficient of 0.999 between absorbance and doravirine concentrations in methanol. Furthermore, the method's LOD and LOQ values were determined. Statistical validation was carried out following the ICH guidelines, which affirmed the precision and accuracy of the method. This validated approach can be efficiently utilized for the regular analysis of doravirine in pharmaceutical dosage forms.

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“…It was approved by the US Food and Medication Administration in 2018 as a complete drug regimen for HIV type 1 infection in patients who had not previously received antiretroviral therapy [12]. According to the literature, few techniques have been published for estimating Lamivudine, Tenofovir, and Doravirine alone and in combination with various dosage forms utilising UV, HPLC methods [13][14][15]. There is no known technique for determining assay and simultaneous estimate of Lamivudine, Tenofovir, and Doravirine in combination dose form.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of New Rp-Hplc Method for The Simultaneous Estimation of Lamivudine, Tenofovir and Doravirine in Pharmaceutical Dosage Form

Srinivas,

devi,

Ramesh

et al. 2023

ijmst

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A simple, accurate, and precise quantitative approach for the simultaneous quantification of Lamivudine, Tenofovir, and Doravarine in pharmaceutical dose form was developed. The chromatogram was performed on an Inertsil C18, 150 * 4.6mm, 5µm column with a mobile phase containing 0.1% orthophosphoric acid and Acetonitrile in a 50:50 v/v ratio that was pumped through the column at a flow rate of 1ml/min. The temperature was kept at 30°C. The optimal wavelength was 230.0 nm. Lamivudine, Tenofovir, and Doravarine had retention times of 2.238, 2.623, and 3.088 minutes, respectively. For three medications evaluated, the % RSD of system precision and method precision was determined to be less than 2%. The mean % recovery for Lamivudine, Tenofovir, and Doravarine was 101.32 percent, 99.94 %, and 100.61 %, respectively. The method was found to be simple, accurate, sensitive,cost effective and can be useful in routine quality control analysis.

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A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral dosage form

Cited by 4 publications

References 18 publications

HPTLC Method for Simultaneous Estimation of Lamivudine, Tenofovir Disoproxil Fumarate, and Doravirine

HPTLC Method for Simultaneous Estimation of Lamivudine, Tenofovir Disoproxil Fumarate, and Doravirine

Creation and validation of a UV spectrophotometric method for the measurement of doravirine in both raw material and pharmaceutical compositions

Development and Validation of New Rp-Hplc Method for The Simultaneous Estimation of Lamivudine, Tenofovir and Doravirine in Pharmaceutical Dosage Form

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