Development and Validation of High Performance Liquid Chromatographic Method for Determination of Lamivudine from Pharmaceutical Preparation

Patro, Saroj Kumar; Swain, Sudhansu Ranjan; Patro, V. J.; Choudhury, N. S. K.

doi:10.1155/2010/490328

Cited by 8 publications

(7 citation statements)

References 3 publications

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“…Further, when acidified Milli‐Q water 0.2% v/v formic acid was tested (0.9 mL/min flow), LAM again exhibited low retention ( t R = 4.19 min) with elution immediately after the solvent front and with low plate count (<2000) while DTG eluted at 5.79 min. Similar retention behavior of LAM was observed in the previous report [36]. To fulfill the aim of simultaneous estimation, retention of both LAM and DTG is a prerequisite.…”

Section: Resultssupporting

confidence: 83%

Box–Behnken design aided optimization and validation of developed reverse phase HPLC analytical method for simultaneous quantification of dolutegravir sodium and lamivudine co‐loaded in nano‐liposomes

Mutalik

Mullick

Pandey

et al. 2021

J of Separation Science

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A stability‐indicating reversed‐phase high‐performance liquid chromatography method for simultaneous estimation of dolutegravir sodium and lamivudine encapsulated in the nanoliposomal formulation was developed. The chromatographic parameters namely, organic phase ratio, flow rate, and sample injection volume were selected as independent factors and were optimized by multivariate Box–Behnken design. Responses analyzed were retention time, peak area, and resolution. The optimized chromatographic method with Hypersil BDS C8 CN column as stationary phase and methanol and acetonitrile mixture and acidified Milli‐Q water (pH 2.8, adjusted with 0.02% v/v orthophosphoric acid) as the mobile phase in an isocratic elution mode was validated according to parameters of International Conference on Harmonization Q1(R2) guidelines. The validated reversed‐phase high‐performance liquid chromatography method exhibited specificity for both dolutegravir sodium and lamivudine in the presence of degradation products as well as the liposomal matrix. This method was effectively utilized to determine the amount of drug entrapped and drug loading efficiency of dolutegravir sodium and lamivudine in a nano‐liposomal formulation.

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Section: Resultssupporting

confidence: 83%

Box–Behnken design aided optimization and validation of developed reverse phase HPLC analytical method for simultaneous quantification of dolutegravir sodium and lamivudine co‐loaded in nano‐liposomes

Mutalik

Mullick

Pandey

et al. 2021

J of Separation Science

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show abstract

“…The quantification of Lamivudine in its pharmaceutical preparations and/or biological samples was described in numerous reports. Analytical methodology involved the use of techniques such as HPLC-UV using different types of columns [4][5][6][7][8][9], spectrophotometry either by direct absorbance measurement [10] or after reacting with different reagents such as ninhydrin, ascorbic acid and using a C18 (octylsilyl) BDS Hypersil ® column (4.6 × 150 mm × 5µm). The mobile phase was prepared by mixing acetonitrile and 50 mM phosphate buffer of pH 4 (adjusted using phosphoric acid) in a ratio of (10:90) v/v.…”

Section: Introductionmentioning

confidence: 99%

Peroxynitrite and Hypochlorite Fluorescence Quantification by S,N and P,N co-Doped Carbon Dots

S¹,

F²,

Ismail³

et al. 2017

Current Trends Anal Bioanal Chem

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A simple, selective, and stability-indicating high pressure liquid chromatographic method with diode array detection was developed for the analysis of lamivudine in tablets. The separation was performed on a C 18 (octylsilyl) BDS Hypersil ® column (4.6 × 150 mm × 5 µm), with isocratic elution of the mobile phase composed of acetonitrile and 50 mM phosphate buffer of pH 4 (adjusted using phosphoric acid) in a ratio of (10:90) v/v. The mobile phase was pumped at a flow rate of 1.0 mL/ min. The detector was set at 280 nm and quantification of the analyte was based on peak area measurement. The method was validated with respect to linearity, range, precision, accuracy, selectivity, robustness, LOD and LOQ. The investigated drug exhibited a linear relationship between concentration and peak area in the range of 5-150 µg/mL with correlation coefficient > 0.999. Lamivudine was subjected to forced degradation studies under two conditions: mild and extensive stress testing. These studies included the effect of hydrolysis (neutral, acidic, and alkaline), oxidation, photolysis, and dry heat. The proposed method proved to be stability-indicating by the resolution of the drug from its forced degradation products, making use of DAD as a tool for peak identity and purity confirmation. By virtue of its sensitivity, the developed method was also extended to analyze lamivudine in biological fluids such as human plasma and urine with good recovery values (Graphical abstract).

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“…After a thorough literature survey it is clear that, there were no any article related to the simultaneous estimation and stability indicating method for combination of lamivudine and dolutegravir sodium by using HPTLC 10,11,12,13,14,15,16,17,18,19 .…”

Section: Fig 2: Chemical Structure Of Dolutegravir Sodiummentioning

confidence: 99%

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2018

IJPSR

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A sensitive, accurate, and precise stability-indicating HPTLC method has been developed for the simultaneous estimation of lamivudine (LMV) and dolutegravir sodium (DOL) in bulk and pharmaceutical dosage formulation. The method employed chloroform: methanol: toluene formic acid (8:2:2:0.2 v/v/v/v) as a mobile phase and silica gel G 60 F254 TLC plates as stationary phase. Chromatographic detection was performed at 271 nm. The R f Value of LMV and DOL was found to be 0.38 ± 0.02 and 0.62 ± 0.02 respectively. The method was validated in compliance with ICH Guideline for linearity, limit of detection (LOD), limit of quantification (LOQ), precision, specificity, accuracy and robustness. The linear regression analysis shown good linear relationship over the concentration range of 120-720 ng/spot for LMV (R 2 = 0.9994) and 20-120 ng /spot for DOL sodium (r 2 = 0.999). The LOD of LMV and DOL was found to be 8.86 ng/spot and 2.92 ng/spot respectively. The LOQ of LMV and DOL was found to be 26.5 ng/spot and 8.74 ng/spot respectively. The % recovery was calculated and found to be 98.83-101.27% for LMV and 98.95-100.97% for DOL respectively. LMV and DOL were subjected to acidic, alkaline, oxidative, neutral and thermal degradation conditions. The degradation products obtained were well resolved from the pure drugs with significantly different R f values. INTRODUCTION: DOL and LMV are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. HIV is a virus that attacks the immune system, which is our body's natural defence against illness. HIV infects vital cells in the human immune system such as helper T cells (specifically CD 4+ T cells), macrophages and dendritic cells 1, 2, 3 .

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Development and Validation of High Performance Liquid Chromatographic Method for Determination of Lamivudine from Pharmaceutical Preparation

Cited by 8 publications

References 3 publications

Box–Behnken design aided optimization and validation of developed reverse phase HPLC analytical method for simultaneous quantification of dolutegravir sodium and lamivudine co‐loaded in nano‐liposomes

Box–Behnken design aided optimization and validation of developed reverse phase HPLC analytical method for simultaneous quantification of dolutegravir sodium and lamivudine co‐loaded in nano‐liposomes

Peroxynitrite and Hypochlorite Fluorescence Quantification by S,N and P,N co-Doped Carbon Dots

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