Spectrophotometric simultaneous determination of Tenofovir disoproxil fumarate and Emtricitabine in combined tablet dosage form by ratio derivative, first order derivative and absorbance corrected methods and its application to dissolution study

Choudhari, Vishnu P.; Ingale, Snehal; Gite, Sacchidanand R.; Tajane, Dipali D.; Modak, Vikram G.; Ambekar, Archana

doi:10.4103/2229-4708.81096

Cited by 26 publications

(13 citation statements)

References 14 publications

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“…For Solid drug dosage form analysis (Lakshmi et al, 2016;Choudhari et al, 2011), 10 tablets were weighed, powdered in a mortar and 200mg of powder Emtricitabine, 25 mg of Rilpivirine and 300 mg of Tenofovir taken into a 50 mL volumetric lask. The whole mixture was dissolved in a suf icient quantity of diluent, and inally, the solution was diluted to 50ml by adding the same diluent up to the mark.…”

Section: Pharmaceutical Formulation Estimationmentioning

confidence: 99%

Emtricitabine, Tenofovir, and Rilpivirine from their degradation products Analysis by HPLC

Kanithi

Kumar

Alumuri

2019

ijrps

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A simple, expeditious, and explicit stability-indicating High-Performance Liquid Chromatography (HPLC) analytical test method was developed for the quantitative analysis of Emtricitabine, Tenofovir, and Rilpivirine in bulk drugs and combined dosage formulations. Using the ICH guidelines method was validated using a C18 column of size 250 mm X 4.6 mm, 5µ, maintained at 25 o C. The total run time maintained was 10 min. Acetonitrile and 0.1% TEA prepared in water adjusted with pH 3.0 was adapted as a mobile phase. The injection volume of samples was 20µL and UV-DAD detector system set at 265 nm used for UV detection. As per the ICH guidelines method was validated. The retention times were observed as 2.52, 3.27, 6.70 min for Emtricitabine, Rilpivirine, and Tenofovir disoproxyl fumarate, respectively. Linearity ranges were observed 24-56 µg/mL Emtricitabine, 3-7 µg/mL Rilpivirine and 30-70 µg/mL Tenofovir. Relative Standard Deviation not exceed 2%. In contract to the conventional method of HPLC, a method developed was able to give better resolution of swift retention times in the separation of various degradation products along with the pure active pharmaceutical ingredients. The proposed method exhibited excellent reproducibility and repeatability. The stress studies performed by following ICH guidelines indicated that the present HPLC method is explicit and stability-indicating. Since the present HPLC method has the capacity to separate the drugs with high resolution in tablet dosage forms, hence the method can be exploited for routine analysis of quality control sample and stability analysis.

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Section: Pharmaceutical Formulation Estimationmentioning

confidence: 99%

Emtricitabine, Tenofovir, and Rilpivirine from their degradation products Analysis by HPLC

Kanithi

Kumar

Alumuri

2019

ijrps

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“…The performance order of the proposed methods is BCP > BTB > BPB. The results obtained and shown in (Tables 2 and 3) were compared to those obtained by a reference method [14] by means of -test at 95% confidence level. In all cases, the average results obtained by proposed methods and reference method were statistically identical, as the difference between average values had no significance at 95% confidence level.…”

Section: Validation Of the Proposed Methodsmentioning

confidence: 99%

“…The literature survey revealed that only few methods are available for the determination of tenofovir in dosage forms and include liquid chromatography with tandem mass spectrometry [4,5]; HPLC with solid phase extraction [6]; reversed phase HPLC [7,8]; HPLC with spectrophotometric detection [9]; HPTLC [10]; gradient ion-pair LC with fluorescent detector [11]; and HPLC-UV, HPLC-MS [12], and first-order UV derivative spectrophotometry [13,14]. Visible spectrophotometry, because of its simplicity, costeffectiveness, sensitivity, selectivity, fair accuracy, and precision, has remained competitive in pharmaceutical analysis.…”

Section: Tenofovir Disoproxil Fumarate (Tdf) 9-[(r)-2-[[bis[(isopropomentioning

confidence: 99%

Extractive Spectrophotometric Determination of Tenofovir Disoproxil Fumarate Using Acidic Triphenylmethane Dyes

Susmitha

Thirumalachary

Singh³

et al. 2014

ISRN Spectroscopy

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Tenofovir disoproxil fumarate is a nucleotide reverse transcriptase inhibitor that has activity against the hepatitis B and HIV viruses. Three simple and sensitive extractive spectrophotometric methods have been described for the assay of tenofovir disoproxil fumarate either in pure form or in pharmaceutical formulations. The developed methods involve formation of colored chloroform extractable ion-pair complexes of the drugs with triphenylmethane dyes, namely, bromothymol blue (BTB), bromophenol blue (BPB), and bromocresol purple (BCP) in acidic medium. The extracted complexes showed absorbance maxima between 410 and 415 nm. Beer's law is obeyed in the concentration ranges 1.5-25, 1.0-25, and 1.25-25 g mL −1 with BTB, BPB, and BCP, respectively. The effectc of concentration of dye, pH, and interference of excipients have been studied and optimized. The limits of detection and quantification have been determined. All three methods are validated as per the guidelines of ICH. The methods have been applied to the determination of drug in commercial tablets and results of analysis were validated statistically through recovery studies.

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“…In last three decades, derivative spectrophotometry has been extensively used in the determination of drugs in multi components having overlapping spectra, which eliminates interference from formulation matrix by using the zero-crossing techniques [1-4]. Ratio-spectra derivative spectrophotometric method is another useful technique for the estimation of drugs in their mixtures [5-8]. …”

Section: Introductionmentioning

confidence: 99%

Simultaneous determination of moxifloxacin and cefixime by first and ratio first derivative ultraviolet spectrophotometry

Attimarad

Al-Dhubiab

Alhaider

et al. 2012

Chemistry Central Journal

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BackgroundThe new combination of moxifloxacin HCl and cefixime trihydrate is approved for the treatment of lower respiratory tract infections in adults. At initial formulation development and screening stage a fast and reliable method for the dissolution and release testing of moxifloxacin and cefixime were highly desirable. The zero order overlaid UV spectra of moxifloxacin and cefixime showed >90% overlapping. Hence, simple, accurate precise and validated two derivative spectrophotometric methods have been developed for the determination of moxifloxacin and cefixime.MethodsIn the first derivative spectrophotometric method varying concentration of moxifloxacin and cefixime were prepared and scanned in the range of 200 to 400 nm and first derivative spectra were calculated (n = 1). The zero crossing wavelengths 287 nm and 317.9 nm were selected for determination of moxifloxacin and cefixime, respectively. In the second method the first derivative of ratio spectra was calculated and used for the determination of moxifloxacin and cefixime by measuring the peak intensity at 359.3 nm and 269.6 nm respectively.ResultsCalibration graphs were established in the range of 1–16 μg /mL and 1–15 μg /mL for both the drugs by first and ratio first derivative spectroscopic methods respectively with good correlation coefficients. Average accuracy of assay of moxifloxacin and cefixime were found to be 100.68% and 98 93%, respectively. Relative standard deviations of both inter and intraday assays were less than 1.8%. Moreover, recovery of moxifloxacin and cefixime was more than 98.7% and 99.1%, respectively.ConclusionsThe described derivative spectrophotometric methods are simple, rapid, accurate, precise and excellent alternative to sophisticated chromatographic techniques. Hence, the proposed methods can be used for the quality control of the cited drugs and can be extended for routine analysis of the drugs in formulations.

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Spectrophotometric simultaneous determination of Tenofovir disoproxil fumarate and Emtricitabine in combined tablet dosage form by ratio derivative, first order derivative and absorbance corrected methods and its application to dissolution study

Cited by 26 publications

References 14 publications

Emtricitabine, Tenofovir, and Rilpivirine from their degradation products Analysis by HPLC

Emtricitabine, Tenofovir, and Rilpivirine from their degradation products Analysis by HPLC

Extractive Spectrophotometric Determination of Tenofovir Disoproxil Fumarate Using Acidic Triphenylmethane Dyes

Simultaneous determination of moxifloxacin and cefixime by first and ratio first derivative ultraviolet spectrophotometry

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