Development and Validation of Stability-Indicating HPLC-DAD Method for Simultaneous Determination of Emtricitabine, Elvetegravir, Cobicistat and Tenofovir in Their Tablet Dosage Forms.

Abstract

A Simple, accurate, specific and rugged reverse phase liquid chromatographic method was developed for the simultaneous estimation of Emtricitabine, Elvetigravir, Cobicistat and Tenofovir in bulk and tablet dosage form. A reverse phase gradient program has been developed to separate the all four active ingredients. The mobile phase consisting of 0.05M Phosphate buffer pH 3.0 (adjusted with dilute phosphoric acid) and Acetonitrile in the ratio 95:5 from 0 min to 4 minutes, further increased the Acetonitrile ratio from 5 to 50 from 4 min to 10 minutes, on a reverse phase C 18 column (250x4.6mm, 5 µ) with a flow rate of 1.0 ml/min, monitored at 240nm. The mean retention times of Emtricitabine, Elvetigravir, Cobicistat and Tenofovir were found to be 1.5, 5.4, 6.6 and 7.5 min respectively. The proposed method was validated in terms of Linearity, Range, Accuracy, Precision, Specificity, Robustness and Ruggedness and the method was successfully applied for the estimation of Emtricitabine, Elvetigravir, Cobicistat and Tenofovir in combined tablet dosage form.

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

“…Extensive literature survey revealed a variety of analytical methods for the estimation of ECT in its pure form, the real samples of dosage forms, and biological fluids. 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. − Several high-performance liquid chromatography (HPLC) techniques have also been used for the quantitative analysis of ECT in its single and combined dosage forms. − The HPLC method has also been reported for the quantitative analysis of ECT in human plasma . Some ultraperformance liquid chromatography (UPLC) methodologies have also been reported for the quantitation of ECT in combined dosage forms. , Several liquid-chromatography tandem mass spectrometry (LC–MS) methodologies have been applied for the quantitative analysis of ECT in combination with other antiviral compounds in human and seminal plasma samples. − Some other techniques like capillary electrophoresis and electrochemical techniques have also been applied for the estimation of ECT in dosage forms. , Several high-performance thin-layer chromatography (HPTLC) techniques have also been used for the quantitative analysis of ECT in its single and combined dosage forms. − However, there is no single study and report on green reversed-phase HPTLC (RP-HPTLC) densitometry analysis of ECT in pharmaceutical dosage forms and biological samples.…”

A Highly Sensitive and Rugged LC-MS/MS Method Development and Validation for Determination of Elvitegravir in Rat Plasma: Application to Pharmacokinetic Study

“…Elvitegravir does not inhibit human topoisomerases I or II. The empirical formula of elvitegravir is C 23 H 23 NO 5 FCl and the molecular weight is 447.883 g/mol. Elvitegravir is a white to pale yellow solid with solubility in dimethyl sulfoxide, acetonitrile and methanol.…”

“…Elvitegravir is metabolized by enzymes as CYP 3A4, a cytochrome P450 isomer To evaluate further pharmacokinetic and pharmacodynamic studies of elvitegravir, a sensitive and simple analytical method is essential for the quantification of elvitegravir concentrations in plasma. For the simultaneous quantification of elvitegravir with other antiviral agents in bulk drugs and tablet formulations [5][6][7][8][9][10][11]. Aditya et al [12] developed a reverse phase high performance liquid chromatography (RP-HPLC) method for the quantification of elvitegravir in rat plasma.…”