Simultaneous Spectrophotometric Method for Determination of Emtricitabine and Tenofovir Disoproxil Fumarate in Three-Component Tablet Formulation Containing Rilpivirine Hydrochloride

Abstract

Developing a single analytical method for estimation of individual drug from a multidrug composition is a very challenging task. A complexation, derivatization, extraction, evaporation, and sensitive-free direct UV spectrophotometric method is developed and validated for the simultaneous estimation of some antiviral drugs such as emtricitabine (EMT), tenofovir disoproxil fumarate (TDF), and rilpivirine HCl (RPV) in tablet dosage form by Vierordt's method. The solutions of standard and sample were prepared in methanol. The λ max⁡ for emtricitabine, tenofovir disoproxil fumarate, and rilpivirine hydrochloride were 240.8 nm, 257.6 nm, and 305.6 nm, respectively. Calibration curves are linear in the concentration ranges 4–12 μg/ml for EMT, 6–18 μg/ml for TDF, and 0.5–1.5 μg/ml for RPV, respectively. Results of analysis of simultaneous equation method were analyzed and validated for various parameters according to ICH guidelines.

Quantitative Analysis of Emtricitabine in Dosage Forms Using Green RP-HPTLC and Routine NP-HPTLC Methods—A Contrast of Validation Parameters

“…Various ultraviolet (UV) spectrometry methods have been proposed for the quantitative analysis of ECT either alone or in combination with other antiviral drugs in pharmaceutical dosage forms. 5 − 10 Several high-performance liquid chromatography (HPLC) techniques have also been used for the quantitative analysis of ECT in its single and combined dosage forms. 11 − 19 The HPLC method has also been reported for the quantitative analysis of ECT in human plasma.…”

Simple thin layer chromatography–ultraviolet spectrophotometric method for quality assessment of binary fixed‐dose‐combinations of lamivudine/tenofovir disoproxil fumarate and lamivudine/zidovudine in tablet formulations

“…The UV spectra of most antiretrovirals such as abacavir (ABA), efavirenz (EFA), tenofovir disoproxil fumarate (TDF), lamivudine (3TC), etc. have maximum absorptions that are very close or the same in some cases, with λ max ranging between 250 and 280 nm in different solvent media [7,18]. Therefore their spectra are either over‐laying or overlapping.…”

“…The use of appropriate chromatographic or solid–liquid separation–extraction technique may help overcome this problem and permit their analysis as individual components. To resolve the difficulties encountered in assaying multicomponent antiretroviral due to the aforementioned challenge of overlain spectra, the use of simultaneous UV spectrophotometric method [7,16,18], derivative spectrophotometric [19–21], and derivative of ratio–spectra methods [19] have been reported. However, these spectrophotometric methods require the application of mathematical expressions and calculations to treat spectra data.…”

A Stability-Indicating Uplc Method for Simultaneous Quantification of Emtricitabine, Efavirenz and Tenofovir Disoproxil Fumarate in Bulk and Pharmaceutical Dosage Forms

“…HIV-2 RT and human cellular DNA polymerases alpha, beta, gamma, and delta are not inhibited by efavirenz. [3] Tenofovir disoproxil fumerate is an adenine derivative and is a pro-drug of tenofovir, chemically known as 9-[(R) The literature survey reveals that many Spectrophotometric [7,8] and HPLC [9][10][11][12] methods were available for the determination of these drugs individually and in combination with other drugs in different dosage forms. Pravish T [13] et al, proposed a validated UPLC method to determine Emtricitabine, Efavirenz and Tenofovir disproxil fumarate simultaneously in synthetic mixture form.…”