Development and validation of RP-HPLC and ultraviolet spectrophotometric methods of analysis for the quantitative estimation of antiretroviral drugs in pharmaceutical dosage forms

Sarkar, Mahua; Khandavilli, Sateesh; Panchagnula, Ramesh

doi:10.1016/j.jchromb.2005.11.014

Cited by 45 publications

(32 citation statements)

References 8 publications

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“…Various mobile phase compositions have been reported (11)(12)(13)(14)(15) for the determination of lamivudine by HPLC. In our study, mixtures of acetonitrile and water in different ratios were tested, and the combination that gave the most favorable retention time was selected.…”

Section: Methods Development and Validationmentioning

confidence: 99%

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

Öztürk¹,

Kaynak²,

Şahin³

2015

Dissolution Technol.

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The aim of this study was to investigate the influence of dissolution medium on the in vitro release of lamivudine (100 mg) from four commercially available lamivudine tablets (one reference and three generic). Three different buffer solutions (pH 1.2, 4.5, 6.8) and deaerated water were used as the dissolution media (900 mL), and the paddle rotation speed was kept at 50 rpm with twelve replicates. An RP-HPLC method was developed for analysis of lamivudine in samples obtained from dissolution studies. The mobile phase consisted of acetonitrile/water (10:90) pH adjusted to pH 2.5 with o-phosphoric acid, a C 18 column (Ace 250 × 4.60 mm, 5 µm) was used, and the flow rate was set at 1 mL/min. All the drugs tested were very rapidly dissolving (more than 85% of the labeled amount in 15 min), and the dissolution profiles of the generic tablets were thus considered similar to that of the reference tablet in each of the buffers at pH 1.2, 4.5, and 6.8, and deaerated water. Because of the dissolution results and the high solubility and borderline permeability, a biowaiver can be proposed for lamivudine immediate-release solid oral dosage forms provided that the excipient composition of the test product is the same as or similar to that of the reference product and the excipients that have an effect on bioavailability are qualitatively and quantitatively the same as that of the reference product.

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Section: Methods Development and Validationmentioning

confidence: 99%

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

Öztürk¹,

Kaynak²,

Şahin³

2015

Dissolution Technol.

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“…The wavelengths used were 285 nm for Abacavir (ABC) [7] and Nevirapine (NVP) [7] [8], 266 nm for Zidovudine (ZDV) [7] [9] and 254 nm for Efavirenz (EFV) [7]. Friabilimeter was of Erweka brand and tablet disintegration was …”

Section: Methodsmentioning

confidence: 99%

UV Visible Spectrophotometric Determination of the Quality of Antiretroviral Drugs Distributed in Kinshasa

Kamangu¹,

Kindenge²,

M.³

et al. 2017

OALib

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Background: Antiretrovirals (ARVs) are the molecules used in the fight against infection by the Human Immunodeficiency Virus (HIV). Their main objective is to stop the virus from replicating and thus allow the immune system to recover. In 2001, the program to fight against HIV/AIDS United Nations (UNAIDS) and its partners has decided to strengthen the pharmaceutical channel and improve access to good quality care. Thus ARV quality control is recommended. Objective: The objective of this work was to monitor the quality of ARVs distributed in Kinshasa. Methodology: In this work, UV-visible spectrophotometry is used for the analysis of ARVs presented in simple form distributed in the city of Kinshasa. Results: The results of this work show that the stated and analyzed ARVs contain active ingredients; there is no placebo. Ten percent of these ARVs are non-compliant with regard to dosing of the active test. Conclusion: These results confirm the need to control these drugs to protect patients from adverse consequences related to their poor quality.

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“…The assay precision can be determined by repeatability (intra-day) and intermediate precision (inter-day) then reported as % relative standard deviation (%R.S.D. ), for a number of experiments which are statistically significant [10] so three concentrations of SFV (10, 30 and 50 µg/mL for the HPLC method and 10, 20 and 30 µg/mL for the UV-spectrophotometric method) were analyzed three times within the same day (intra-day) or on three successive days (inter-day) then the results were documented as %R.S.D.…”

Section: Precisionmentioning

confidence: 99%

“…Specificity can be determined by comparing the HPL chromatogram and the UV-scan obtained for a mixture of SFV and the commonly used excipients, with those obtained from the blank (excipients solution in methanol without drug) [10]. The chosen excipients were microcrystalline cellulose, colloidal silicon dioxide, mannitol, croscarmellose sodium, and magnesium stearate.…”

Section: Specificitymentioning

confidence: 99%

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Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms

Abdel-Gawad¹

2016

Eur. J. Chem.

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Two methods, a reversed phase high-performance liquid chromatographic (RP-HPLC) method and a direct ultra-violet spectrophotometric method, were adopted and validated for the quantification of sofosbuvir, which is a new antiviral agent used for treatment of patients with hepatitis C virus (HCV). Validation parameters such as linearity, accuracy, precision, specificity, limits of detection and quantification were determined according to the guidelines of International Conference on Harmonization (ICH)-Q2B. The RP-HPLC method was applied on Hypersil TM ODS C18 column (150×4.6 mm, 5 µm) as a stationary phase. The mobile phase was optimized according to the polarity of the studied drug. It was methanol: acetonitrile (90:10, v:v), pumped using an isocratic mode with flow rate of 1 mL/min and UV detection at 260 nm. The UV spectrophotometric method was performed for the studied drug at 260 nm. The calibration curves were linear in the ranges of 2-60 µg/mL and 5-40 µg/mL for the RP-HPLC and UV spectrophotometric methods, respectively. The proposed methods are accurate, sensitive and precise, so they can be successfully adopted for the reliable determination of sofosbuvir content in its tablet form.

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Development and validation of RP-HPLC and ultraviolet spectrophotometric methods of analysis for the quantitative estimation of antiretroviral drugs in pharmaceutical dosage forms

Cited by 45 publications

References 8 publications

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

Comparison of Dissolution Profiles of Commercially Available Lamivudine Tablets

UV Visible Spectrophotometric Determination of the Quality of Antiretroviral Drugs Distributed in Kinshasa

Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms

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