Simultaneous Determination of Lamivudine, Zidovudine and Abacavir in Tablet Dosage Forms by RP HPLC Method

Kumar, D. Anantha; Rao, G. Srinivasa; Rao, J. V. L. N. Seshagiri

doi:10.1155/2010/473798

Cited by 19 publications

(16 citation statements)

References 4 publications

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“…Previously few methods [5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] are available for analysis of NVP in formulations and bulk drug.Ch Venkata Reddiah et al 20 reported one HPLC method for analysis of NVP and its impurities. While developing method at initial stage of the methoddevelopment trials done with NH 4 H 2 PO 4, Sodium per chlorate buffer solution at different pH and acetonitrile as solvent and C18 column but the separation of NVP and Impurity-Ais not good.…”

Section: Resultsmentioning

confidence: 99%

High Resolution RP-HPLC Method for the Determination of Nevirapine and Associated Impurities

Phani¹,

Prasad²,

Mallu³

2015

Orient. J. Chem

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Objective of the present research work is to develop a sensitive, selective and accurate new RPHPLC method with UV detection and determination for estimation of Nevirapine (NVP)and its impurities in bulk drug. The separation and quantification was achieved with Kromosil C18 isocratic column, (150 mm × 4.6 mm i.d., particle size 3.5 µm, maintained at ambient temperature), HPLC system (Peak LC P7000), a mixture of 20% acetonitrile, 80% buffer (sodium per chlorate) (v/v), at pH of 4.8 and the flow rate was set at 1.0 ml/min. and UV detection at 220 nm. The retention time for NVP, Impurity-A and Impurity-B were found to be 5.5, 7.8, 3.4 min respectively. The method was validated for Linearity, Accuracy, and Precision. The Limit of detection of NVP, Impurity-A and Impurity-B were found to be 0.03, 0.03, 0.03(µg/ml) respectively.

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Section: Resultsmentioning

confidence: 99%

High Resolution RP-HPLC Method for the Determination of Nevirapine and Associated Impurities

Phani¹,

Prasad²,

Mallu³

2015

Orient. J. Chem

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“…Although various methods like HPLC-UV, LC-MS/MS, HPTLC are available, these methods are expensive due to use of expensive detectors, costly solvents, columns and also more time needed to develop and validate the method. [14][15][16] The present IR spectroscopy method is a simple, rapid, accurate and cost effective analytical tool for AZT determination in tablet formulations.…”

Section: Discussionmentioning

confidence: 96%

A quantitative analysis of Zidovudine containing formulation by FT-IR and UV spectroscopy

2010

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In this study IR and UV spectroscopic procedures are describe for the quantitative determination of Zidovudine (AZT) from solid dosage form. For IR spectroscopic method (KBr disc technique) has been used and Ursodeoxycholic acid (UDCA) was used as an internal standard. The specific absorption bands at 2105 and 2931 cm À1 were chosen for AZT and UDCA respectively. In this method, beer's law was obeyed in the concentration range 0.8-2.0% w/w in KBr disc. The regression equation was found to be y ¼ 1.088x + 1.194 with correlation coefficient 0.9819, and the assay was found to be 99.8% with RSD of 2.157%. The UV spectroscopic method was also used in the quantitative determination of AZT in solid dosage form. 266 nm was chosen as l max . The regression equation was found to be y ¼ 0.0434x + 0.027, and the correlation coefficient 0.9989. The assay was found to be 99.81% with RSD of 0.273% by the UV spectroscopic method.

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“…First is the cost effectiveness of the system as methanol is the only organic solvent that has been used for the method development. Other systems mostly used acetonitrile as the major organic solvent and in some cased even used a combination of various organic solvents and phosphate buffer which would increase the operating cost if such analysis has to be performed in a regular basis [9,13,[18][19][20]. Methanol is cheaper, supposedly less damaging to health.…”

Section: Application Of the Analytical Methodmentioning

confidence: 99%

“…Various HPLC analysis methods have been reported for the analysis of different NRTIs and NNRTIs but there is lack of a simple, cost effective, definitive stability indicating method for analyzing the combination of 3TC, AZT and NVP that can be used in a FDC formulation [9][10][11][12][13]. Hence, the main objective of this study is to develop a simple and robust stability indicating HPLC-UV method for the simultaneous determination of the three analytes together with their possible degradants.…”

Section: Introductionmentioning

confidence: 99%

Reversed Phase LC-UV Method Development and Validation for Simultaneous determination of three antiretrovirals: Lamivudine, Zidovudine, Nevirapine and Possible Degradants in a Fixed Dose Pharmaceutical Product

Joshi¹,

Adeyeye²

2012

J Pharm Technol Drug Res

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Background: Lamivudine (3TC), Zidovudine (AZT) and Nevirapine (NVP) are the common antiretrovirals prescribed in resource limited countries due to its cost effectiveness compared to other newer antiretrovirals. Monitoring quality of such generic versions of the dosage forms is a crucial aspect. The main aim of the study is to develop a simple reversed phase (RP) HPLC-UV method to determine 3TC, AZT, NVP with some of its degradation products cytosine and thymine that can be applied in monitoring the quality of such products. Methods: A RP gradient HPLC method was developed using following chromatographic conditions: LunaC18 150 x 4.6mm column; 50mM ammonium acetate buffer (pH = 6.8) and methanol as mobile phase; Gradient mode of elution with 0-35%v/v methanol for first 10 minutes increased to 50%v/v till 12 minutes and isocratic to 18minutes, return to initial at 20min; sample injection volume 50μl; detection wavelength 265nm. Calibration ((n= 6) and validation samples (n=3) were prepared in triplicate for analysis and validated for specificity, linearity, range, accuracy and precision. The method was used in dissolution studies of the fixed dose combination tablets of AZT/3TC/NVP using USP Type I method. Results: No interference between the analytes was observed. The method was found to be linear over the following concentration range for the five analytes: Cytosine and thymine (0.5-8μg/ml), 3TC (1-50μg/ml), AZT and NVP (1-80μg/ml) with coefficient of determination (R2) value > 0•9997. Accuracy in terms of mean percent recovery for the five analytes was found to in the range of (Mean Recovery ± S.D) 101.26± 1.27%. Intra-day and Inter-day precision (%RSD) was found to be 0.49± 0.28% and 2.24 ± 0.26% respectively. There were no significant differences in the mean recovery of the APIs between the days as analyzed by two-way ANOVA at p >0•05. No matrix effect due to the presence of other excipients in the formulation was observed in the chromatograms of the dissolution samples. Conclusion: The method developed was specific, accurate, reliable and can be applied during routine pharmaceutical analyses such as drug content analysis, dissolution studies and stability of the fixed dose combination product of AZT/3TC/NVP.

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Simultaneous Determination of Lamivudine, Zidovudine and Abacavir in Tablet Dosage Forms by RP HPLC Method

Cited by 19 publications

References 4 publications

High Resolution RP-HPLC Method for the Determination of Nevirapine and Associated Impurities

High Resolution RP-HPLC Method for the Determination of Nevirapine and Associated Impurities

A quantitative analysis of Zidovudine containing formulation by FT-IR and UV spectroscopy

Reversed Phase LC-UV Method Development and Validation for Simultaneous determination of three antiretrovirals: Lamivudine, Zidovudine, Nevirapine and Possible Degradants in a Fixed Dose Pharmaceutical Product

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