Journal of Advanced Pharmaceutical Science And Technology

Journal of Advanced Pharmaceutical Science And Technology

Journal of Advanced Pharmaceutical Science and Technology

Current Issue Volume No: 2 Issue No: 3

Review Article Open Access Available online freely Peer Reviewed Citation

Review article on Analytical Techniques of Lamivudine Determination in Different Matrices

Roshdy E. Saraya 1,   Magda Elhenawee 2,   Hanaa Saleh 2,   Mahmoud M. Sebaiy 3  

1Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Port Said University, Port Said, 42511, Egypt.

2Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt.

3Department of Medicinal Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt.

Abstract

In this literature review, we will introduce most of up-to-date reported methods that have been developed for determination of lamivudine in its pure form, combined form with other drugs, combined form with degradation products, and in biological samples.

Author Contributions
Received 13 Dec 2020; Accepted 31 Dec 2020; Published 05 Jan 2021;

Academic Editor: Fatma Mohammed Mady, Department of Pharmaceutics, Minia University, Egypt.

Checked for plagiarism: Yes

Review by: Single-blind

Copyright ©  2021 Roshdy E. Saraya, et al.

License
Creative Commons License     This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Competing interests

No author has any associations that may represent a potential conflict of interest.

Citation:

Roshdy E. Saraya, Magda Elhenawee, Hanaa Saleh, Mahmoud M. Sebaiy (2021) Review article on Analytical Techniques of Lamivudine Determination in Different Matrices. Journal of Advanced Pharmaceutical Science And Technology - 2(3):37-46. https://doi.org/10.14302/issn.2328-0182.japst-20-3664

Download as RIS, BibTeX, Text (Include abstract )

DOI 10.14302/issn.2328-0182.japst-20-3664

Introduction

Lamivudine

(LAM) is an analogue of cytidine. It can inhibit both types HIV-1 and HIV-2 reverse transcriptase and also the reverse transcriptase of hepatitis B virus. It is phosphorylated to active metabolites that compete for incorporation into viral DNA. They inhibit the HIV reverse transcriptase enzyme competitively and act as a chain terminator of DNA synthesis 1. The lack of a 3'-OH group in the incorporated nucleoside analogue prevents the formation of the 5' to 3' phosphodiester linkage essential for DNA chain elongation, and therefore, the viral DNA growth is terminated 2.

As such, in this literature review, we will introduce most of up-to-date reported methods that have been developed for determination of LAM in its pure form, combined form with other drugs, combined form with degradation products, and in biological samples.



Review of Analytical Methods

Various techniques were used for the analysis of RIT in pure forms, in their pharmaceutical formulations and in biological fluids. The available reported methods in the literature can be summarized as follows: Table 1.

Table 1. Spectrophotometric Methods
Drugs Method or reagent λmax Ref
LAMand zidovudine First drivative spectrphotometry 239.5 and 245.3 nm for LAM and 225.1 and 251.5 nm for zidovudine 3
LAM and stavudine First drivative spectrphotometry 280 for stavudine and 300 nm for LAM. 4
LAM and stavudine 3-methyl-2-benzothiozolinone hydrazone hydrocloride and ferric chloride 660 nm for LAM and 630 nm for stavudine 5
LAM chloramine-T and methyl orange, or chloramine-T and indigo carmine 520nm or 610nm 6
LAMand zidovudine derivative spectrophotometry 246 nm for LAM and 263 nm for zidovudine 7
LAM N HCl0.1 N NaOH 279.6 nm269.8 nm 8
Tenofovir, Disoproxil and LAM Simultaneous equation methodMulticomponent analysisDerivative spectroscopy method 247, 259 and 272 nm  9
LAMand zidovudine Derivative Spectrophotometry 242, and 236 nm 10
LAM methyl orange and indigocarmine 520n and 610 nm 11
LAMand zidovudine UV spectroscopy and multivariate calibration 250 and 267 nm 12
LAM and efavirenz overlain spectra method 271 and 247 nm 13
LAM chloranilic acid and 2,3-dichloro-5,6-dicyano-1,4-benzoquinone 221 and 230 nm 14
LAM, nevirapine and zidovudine overlain spectra method 280.2nm, 312nm and 266.8nm  15
LAM, Sofosbuvir,and Ritonavir Silver nanoparticles synthesis 421 nm for Sofosbuvir and Ritonavir and at 425 nm for Lamivudine LAM 16

2. Chromatographic Methods

(Table 2 a, Table 2 b.)

Table 2 a. HPLC
Matrix Column Mobile phase system Ref
plasma Aquasil C18 column ACN : water (15:85 v/v) HPLC–MS/MS 17
Tablet Spherisorb® C18 analytical column methanol: water: ACN (70:20:10 (v/v/v)) HPLC-UV 265 nm 3
plasma a Shim-pack® C8 column Sodium dihydrogen phosphate monohydrate (10 mM): methanol:ACN (94:3:3, v/v/v, pH 4.8) HPLC-UV 270 nm 18
plasma Phenomenex C8 column A gradient elution with 20 mM ammonium acetate buffer with pH 4.5 : ACN HPLC–MS/MS 19
Tablet Symmetry C18 column methanol: water (20:80 v/v) HPLC-UV 270 nm 4
Tablet C18 column A gradient elution with 80% of 10 mM acetate buffer (pH 3.5): 20% methanol: 50% CAN: 50% isopropyl alcohol. HPLC-UV 270 nm 20
Plasma and saliva Zorbax SB-C18 column  0.005 M di potassium hydrogen phosphate solution in water (pH 6.8): methanol (92:8 v/v). HPLC-UV 270 nm 21
Tablet HiQ SilC18 column 0.01 M potassiumdi hydrogen orthophosphate (pH 3.0): methanol (55:45 v/v) HPLC-UV 272 nm 22
plasma C18 column a mixture of phosphate buffer (0.05 M) containing TEA (1 mL/L pH 3.5): methanol (91:9, v/v) HPLC-UV 276 nm 23
plasma Lichrospher® RP‐ C18 column 20 mM ammonium acetate: methanol containing 1% of acetic acid (60:40 v/v) HPLC–MS/MS 24
plasma a phenyl column with Phenomenex C18 guard column 5% methanol in 20 mM dibasic phosphate buffer (pH 6). HPLC-UV 256 nm 25
plasma octylsilane column 20 mM sodium phosphate buffer with (8 mM 1 octane sulfonic acid sodium salt): ACN (86:14, v/v) HPLC-UV 265 nm 26
plasma C18 analytical column CAN: water (9:91, v/v) HPLC-UV 271 nm 27
plasma Aquasil C18 column ACN: water (15:85, v/v) HPLC–MS/MS 28
plasma A Symmetry Shield RP C18 column A gradient elution with acetate buffer (20 mM potassium acetate pH 4.60): ACN HPLC-UV 260 nm 29
plasma a Shiseido C8 column a gradient elution with methanol: water (80:20, v/v) and water, both containing 10 mM ammonium acetate HPLC –MS/MS 30
Plasma a Spherisorb® C18 analytical column methanol: water (75 : 25, v/v) HPLC-UV at 265 nm 31
Plasma a C18 column CAN: water (13:87, v/v) HPLC-UV at 220 nm 32
Tablet Thermo Hypersil Gold C18 column Agradiant elution with 20 mM sodium phosphate buffer (pH 3.5) with phosphoric acid : methanol HPLC-UV at 265 nm 33
Plasma a C18 column 0.01M sodium dihydrogen phosphate : methanol: ACN (4 : 2 : 3 v/v/v) HPLC-UV at 285 nm 7
Plasma Phenyl column C18 column ACN: 0.085% phosphoric acid (12:88, v/v) HPLC-UV at 270 nm 34
Plasma Aquasil® C18 A gradient elution with 0.05% FA in either water or methanol HPLC – MS/MS 35
Plasma Zorbax® C18 column methanol: water: phosphate buffer (pH 5.65) (80:10:10; v/v/v) HPLC-UV at 275 nm 36
Plasma A Phenomenex C18 Methanol: Water (85:15%v/v) HPLC-UV at 270 nm 37
Plasma and tissues a phenyl column 8% ACN in 5 mm 1‐heptane sulfonic acid dissolved in 30 mm AF buffer (pH 3.3). HPLC-UV at 254 nm 38
Plasma a Vydac C18 column  A gradient elution, both CAN and ultrapure water solvents contained 0.2% FA. HPLC – MS/MS 39
Rabbit plasma Hypersil BDS C-18 column 0.25% Triethylamine buffer (pH 3.0): CAN (70:30, v/v) HPLC-UV at 256 nm 40
Plasma Zorbax SB C8 column A gradient elution with methanol: acetic acid sodium acetate buffer (pH 3.9) HPLC-UV at 260 nm 41
Plasma Prontosil C18 column 1 mM ammonium acetate in water (pH 6.5 ± 0.3): ACN (50:50 v/v) HPLC – MS/MS 42
Plasma A Chromolith C18 column 50 mM sodium dihydrogen phosphate : TEA (996:4 v/v) HPLC-UV at 278 nm 43
Plasma An ACE 5 CN column 0.5% FA in water: ACN (55:45, v/v) HPLC – MS/MS 44
Rat tissue a C18 column methanol: 7.5 mM ammonium acetate (30:70, v/v) HPLC – MS/MS 45
Plasma Pack VP - ODS C18 column phosphate buffer (pH7.0): ACN : methanol (91:0.1:9) HPLC-UV at 274 nm 46
Plasma a C18 column A gradient with 0.1% FA in water and 0.1% FA in methanol HPLC – MS/MS 47
Tablet a C18 column water: methanol (60:40 v/v) HPLC-UV 270 nm 48
Plasma A Phenomonex C18 column A queous solution of 15% ACN and 0.1% acetic acid HPLC – MS/MS 49
Tablet A bondapak C18 0.02 M tri-sodium citrate and methanol (70:30 v/v) HPLC-UV at 266 nm 50
Tablet A thermo BDS C18 column A formic acid and methanol in the ratio of 50:50 HPLC-UV at 264 nm 51
Plasma a C8 column A gradient elution with 10 mM potassium phosphate, 3% ACN, and methanol HPLC-UV at 272 nm 52
Tablet a Hypersil BDS, C18 column o- phosphoric acid: methanol (70:30) HPLC-UV at 220 nm 53
Plasma A Peerless Basic C18 column 0.1% formic acid in water: methanol (15:85, v/v) HPLC – MS/MS 54
Tablet a C18 column methanol and water (89:11 v/v) HPLC-UV at 272 nm 55
Tablet a Diamonsil Cl8 column 0.025 mol ammonium acetate (pH 3.9 ± 0.1)-methanol (90:10). HPLC-UV at 270 nm 56
Plasma a C18 column A gradient elution with 10 mM acetate buffer (pH 6.5)- ACN HPLC-UV at 265 nm 57
Plasma a Hypurity Advance C18 ACN :0.1% FA (76:24, v/v) HPLC – MS/MS 58
Tablet A LunaC18 A gradient elution with 50mM ammonium acetate buffer (pH = 6.8) and methanol HPLC-UV at 265 nm 59
plasma a Hypersil BDS, C18 column 0.1 M ammonium acetate buffer in 0.5% acetic acid, v/v and methanol (40:60, v/v) HPLC-UV at 270 nm 60
Tablet An YMC pack C8 column buffer pH 3.5: methanol (90:10 v/v) HPLC-UV at 265 nm 61
Tablet a Kromasil C18 analytical column methanol: 10 mM phosphate buffer (pH 5.0) (70:30 v\v). HPLC-UV at 254 nm 62
Tablet A Luna C18 0.1 % triethylamine (pH 5.11: ACN (70:30) HPLC-UV at 245 nm 63
Tablet a Luna hydrophilic interaction column ACN /10 mM ammonium formate (95:5, v/v) HPLC – MS/MS 64
Tablet a C18 column Agradient elution with 0.05 M Phosphate buffer (pH 6.2): ACN HPLC-UV 260 nm 65
Tablet A Phenomenex Luna C18 column ACN : methanol: water 30: 45: 25 (v/v/v) HPLC-UV 258 nm 66

Table 2 b. HPTLC
Matrix Stationary phase Mobile phase detector Ref
Tablet silica-gel 60 F254 plate toluene/chloroform/methanol (1:6:3 v/v/v) UV- 276 and 271 nm 67
Tablet silica-gel 60 F254 plate Acetone: chloroform:methanol (4: 4: 2 v/v/v) UV- 265nm 68
Tablet silica-gel 60 F254 plate chloroform: methanol: toluene (8: 2: 2, v/v/v) UV- 265nm 69
Tablet silica-gel 60 F254 plate ethyl acetate, methanol, toluene and conc ammonia (38.7:19.4:38.7:3.2, v:v:v:v) UV- 254nm 70
Tablet silica-gel 60 F254 plate n-hexane: chloroform: methanol (1:7:2 v/v/v) UV- 275 nm 71

Other Methods

Titremetry 6, 11, capillary electrophoresis 72, 73, chemometry 74, Voltamitry 75.

Conclusion

This literature review represents an up to date survey about all reported methods that have been developed for determination of the anticancer drug, lamivudine in its pure form, combined form with other drugs, combined form with degradation products, and in biological samples such as liquid chromatography, spectrophotometry, electrochemistry, etc...

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