Analytical Method Development and Validation of Stability Indicating assay method of analysis for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate tablets using High Performance Liquid Chromatography

The derivative spectrophotometric methods are the goal of evaluating the simultaneous level of Dextromethorphan HBr and Glyceryl Guaiacolate mixture in Syrup. The determination of the mixture is used the derivative spectrophotometry method with methanol-water (50:50) for Dextromethorphan HBr and Glyceryl Guaiacolate. The derivative spectrophotometric method on 1st derivatization with ∆λ 2 nm have wavelength 263.6 nm for Dextromethorphan HBr and 2nd derivatization with ∆λ 2 nm at 285 nm for Glyceryl guaiacolate, The locally producted syrup samples met the level requirements mixture of Dextromethorphan and Glyceryl guaiacolate less than 90.0% and not over 110.0% of the amount stated on the label. The validation test showed that these two methods had met the validation parameter. The derivative spectrophotometry method was used to determine a mixture of Dextromethorphan HBr and Glyceryl guaiacolate and fulfilling the validation requirements and level requirements according to USP 30.

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Evaluation of Dextromethorphan HBr and Glyceryl Guaiacolate mixture in syrup preparation by Derivative Spectrophotometry Methods

Muchlisyam

Permata

Syahputra

2022

RJPT

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A new Stability-indicating UHPLC for the simultaneous determination of a combination of Anti-viral drugs: Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate

Kota

Annapurna

2022

RJPT

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Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate are anti-viral drugs. A new stability indicating UHPLC method has been proposed for the simultaneous determination of Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate tablets on gradient mode with 1.0mL/min flow rate and a diluent consisting of a mixture of phosphate buffer (pH 3.0) and acetonitrile (62: 38) was used for the study. Shimadzu NexeraX2 Model UPLC system with (PDA detector) Zorbax SB-C18 column (100mm × 4.60mm, 3.5μ) was employed for the present study. Beer-Lambert’s law was obeyed over the concentration range 5-900, 2-700 and 2-150µg/mL with linear regression equationsy = 1724.x-11307 (R² = 0.999), y = 1737.x-1009 (R² = 0.999) and y = 3538.x+587.5 (R² = 0.999) for Lamivudine, Tenofovir disoproxil fumarate and Dolutegravir sodium and the method was validated as per ICH guidelines. The LOQ values were found to be 4.4926, 1.8342 and 1.7963 µg/mL and that of LOD values as 1.4811. 0.6024 and 0.5903µg/mL forD Lamivudine, Tenofovir disoproxil fumarate and Dolutegravir sodium respectively. The combination of Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate was exposed to various stress conditions and the stability of the proposed method was carried out at UV detection 260nm. The proposed UHPLC method is simple, precise, accurate, robust and used for the routine analysis of tablet dosage forms.

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Development and Validation of Stability-indicating assay UHPLC Method for Simultaneous analysis of Dolutegravir, Lamivudine and Tenofovir disoproxil fumarate in Bulk and Pharmaceutical Formulation

Thakare

Mittal

Charde³

et al. 2022

RJPT

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A stability indicating UHPLC method has been developed to analysis of Dolutegravir (DLT), Lamivudine (LVD), and Tenofovir Disoproxil Fumarate (TDF). The separation was achieved by using UPLC BEH C18 (150mm 2.1mm) with 1.7 µm particle size column at ambient temperature using solvent system in a proportion of (40:60% v/v) acetonitrile:water; pH 6.5 was adjusted with 0.1% OPA. The solvent system was filtered prior to the start of the chromatographic analysis through a 0.2μm membrane (Ultipor N66 Nylon 6, 6) and sonication of it for 20min. A 10μL of fixed volume (working solution) was injected and the chromatogram was studied at a detection wavelength of 262 nm. The proposed method was validated in terms of Linearity, Accuracy, Precision, Ruggedness, Robustness and stability studies. The chromatographic analysis time was approximately less than 3 minutes with complete resolutions of DLT (Rt = 1.35min), LVD (Rt = 0.69min) and TDF (Rt = 2.36min). The method exhibited good linearity range, 3-18 μg/mL, 10-60 μg/mL and 10-60 μg/mL of DLT, LVD and TDF respectively. The % amount of DLT, LVD and TDF in marketed formulation were recorded to be 99.59 ± 0.44, 99.81 ± 0.48 and 99.47 ± 0.59 respectively. The force degradation studies were performed as per ICH guidelines under the acidic, alkali oxidative and neutral conditions for different times. Therefore the developed UHPLC method can be applied for routine qualitative and quantitative analysis of DLT, LVD and TDF in bulk and pharmaceutical formulation and validated as per theICH guidelines and could be employed for the stability studies on pharmaceutical preparation within pharmaceutical industry.

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Analytical Method Development and Validation of Stability Indicating assay method of analysis for Dolutegravir/Lamivudine/Tenofovir Disoproxil Fumarate tablets using High Performance Liquid Chromatography

Cited by 5 publications

References 10 publications

Evaluation of Dextromethorphan HBr and Glyceryl Guaiacolate mixture in syrup preparation by Derivative Spectrophotometry Methods

Evaluation of Dextromethorphan HBr and Glyceryl Guaiacolate mixture in syrup preparation by Derivative Spectrophotometry Methods

A new Stability-indicating UHPLC for the simultaneous determination of a combination of Anti-viral drugs: Dolutegravir sodium, Lamivudine and Tenofovir disoproxil fumarate

Development and Validation of Stability-indicating assay UHPLC Method for Simultaneous analysis of Dolutegravir, Lamivudine and Tenofovir disoproxil fumarate in Bulk and Pharmaceutical Formulation

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