A new stability indicating RP-HPLC method development and validation for simultaneous estimation of emtricitabine and tenofovir with degradation kinetics.

Sumanth, Kamatham Srinivas; Rao, A. Srinivasa; Shankar, D Gowri

doi:10.5958/0974-4150.2018.00102.5

Asia. Jour. Rese. Chem.

2018

DOI: 10.5958/0974-4150.2018.00102.5

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A new stability indicating RP-HPLC method development and validation for simultaneous estimation of emtricitabine and tenofovir with degradation kinetics.

Kamatham Srinivas Sumanth¹,

A. Srinivasa Rao²,

D Gowri Shankar³

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Recent Advances in Analytical Method Development and Validation Techniques for Anti-HIV Pharmaceuticals of Tenofovir

Avhad,

Morkar,

Shinde

et al. 2023

Biosci., Biotech. Res. Asia

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Many questions have been raised regarding the management of acquired immunodeficiency syndrome (AIDS) which is caused by a retrovirus called as HIV, (human immunodeficiency virus) is what causes AIDS. Infection caused by HIV is particularly the world's most serious health and development challenges. Although there is no known complete cure for HIV, several drugs can help you stay healthy by lowering the amount of HIV in your body. When treating HIV infection, antiretroviral therapy is used, and a variety of medications are available from this category. Tenofovir and its salt versions, both by themselves and in combination with emtricitabine, are the most often utilized medications. HIV levels should be lowered so that your immune system can function more effectively. This article offers a summary and evaluation of several analytical techniques used on the antiretroviral medication tenofovir over the previous five years. It covers forced degradation, HPLC and RP-HPLC, HPTLC, UPLC and RP-UPLC, LC-MS.

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Recent Advances in Analytical Method Development and Validation Techniques for Anti-HIV Pharmaceuticals of Tenofovir

Avhad,

Morkar,

Shinde

et al. 2023

Biosci., Biotech. Res. Asia

View full text Add to dashboard Cite

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Reverse Phase High Performance Liquid Chromatographic Method for Separation and Estimation of impurities present in Pharmaceutical Formulation of Empaglifozin

Patel

2021

RJPT

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Empaglifozin is a Sodium-glucose co-transporter-2 inhibitors work by inhibiting SGLT2, to prevent reabsorption of glucose and facilitate its excretion in urine. Impurities in pharmaceuticals which are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs), or develop during stability testing, or develop during formulation or upon aging of both API and formulation. A simple and very sensitive method developed for estimation of impurities present in Empaglifozin formulation by Reverse Phase High Performance Liquid Chromatographic method. Method is capable to detect impurities in very low level (1µg/mL). Chromatographic separation of six different impurities was achieved on Inertsil ODS-2 (250 x 4.6) mm, 3µm column using gradient elution method at 30°C column temperature and the detection was carried at 230nm at a flow rate of 1.0 mL/min. The method was validated as per ICH Q2(R1) guideline along with stress studies.

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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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A new stability indicating RP-HPLC method development and validation for simultaneous estimation of emtricitabine and tenofovir with degradation kinetics.

Cited by 3 publications

References 0 publications

Recent Advances in Analytical Method Development and Validation Techniques for Anti-HIV Pharmaceuticals of Tenofovir

Recent Advances in Analytical Method Development and Validation Techniques for Anti-HIV Pharmaceuticals of Tenofovir

Reverse Phase High Performance Liquid Chromatographic Method for Separation and Estimation of impurities present in Pharmaceutical Formulation of Empaglifozin

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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