Analytical Methods for Determination of Lamivudine and their Applicability in Biological Studies

 

Nalini C. N.*, Nithya. A, Afnaan Afreen, A. Ashraf  Banu, Hemalatha. P, E. J. Gayathri

C. L. Baid Metha College of Pharmacy, Chennai-97

 

ABSTRACT:

The drug development plays an important role in maintaining thehuman health.To confirm that the developed pharmaceuticals have the prescribed standards various chemical and instrumental methods were developed. These methods are also useful in reducing the impurities present in the drug moieties developed. Antiretroviral therapy(ART) is the combination of several antiretroviral medicines used to retard the growth rate of HIV in the body. Lamivudine is one of those antiretroviral drugs, that comes under the class of nucleoside reverse transcriptase inhibitors (NRTIs), used primarily in the treatment of AIDS and hepatitis B infection. This review highlights a variety of analytical techniques such as chromatographic, spectroscopic and other techniques; HPLC and HPTLC are most commonly preferred for their high sensitivity and accuracy. By reviewing these latest methods it will become easier for future researchers to make an informed choice. The article focuses on the recently developed and validated methods, both in vivo and in-vitro that are currently used for Lamivudine individually or in combination with other drugs.

 

 

 

INTRODUCTION:

Antiretroviral therapy(ART) is the combination of several antiretroviral medicines used to retard the growth rate of HIV in the body. This kind of treatment is more effective than monotherapy against the retrovirus (HIV). They provide, palliative treatment by prolonging and improving the quality of life and postponing complications of AIDS or AIDS related complex (ARC), without treating the actual disease. The clinical efficacy of anti retrovirus drugs is monitored primarily by plasma HIV-RNA assays and CD4 lymphocyte count carried out at regular intervals. And several methods that are used in the analysis of lamivudine is summarised.

 

Anti retroviral drug that are used to treat HIV include:

Nucleoside/Nucleotide reverse transcriptase inhibitors

They are also called as nucleoside analogs . Drugs may include, zidovudine, lamivudine, abacavir emtricitabine and tenofovir.

 

Nonnucleoside reverse transcriptase inhibitors (NNRTIs):

Drugs such as efavirenz, etravirine and nevirapine comes under this class.

 

Protease inhibitors (PIs):

PIs such as atazanavir, darunavir and ritonavir.

 

Entry inhibitors:

Drugs such as enfuviritide and maraviroc.

 

Integrase inhibitors:

Such as dolutegravir and raltegravir.

 

Lamivudine, which comes under nucleoside/nucleotide reverse transcriptase inhibitor commonly called as 3TC, an antiretroviral medication used to prevent and treat HIV/AIDS which acts by scientifically inhibits the viral reverse transcriptase. It is also used to treat hepatitis B. It is effective against both HIV-1 and HIV-2. It is generally used in combination with other antiretroviral such as zidovudine and abacavir. Lamivudine is taken by oral route as tablet or as oral solution.

 

 

 

General methods used in the analysis of lamivudine:

·       RP-HPLC.

·       UV Spectroscopy and Q-Analysis.

·       HPTLC.

·       UPLC.

·       CWT And DS.

·       MLC.

 

UV-Spectroscopy.

S. No	DRUG	METHOD	INSTRUMENTAL PARAMETERS	RESULTS OF VALIDATION	REF
1	Zidovudine, Lamivudine	UV	Jasco V650 double beam UV  Visible spectrophotometer, 0.1N HCl, L:256nm &275.2nm Z:272nm & 287.2nm	Linearity : L: 50-275 µg/ml, Z:50-425 µg/ml Cor.Coeff: L:0.998, Z:0.999 LOD: L: 15.74 µg/ml, Z: 5.79 µg/ml LOQ: L: 47.69 µg/ml, Z: 17.56 µg/ml	1
2	Lamivudine, Efavirenz	UV	UV double beam spectrophotometer (Shimadzu model 1800), Acetonitrile L:271nm E:247nm	Linearity: L:10-100 µg/ml, E:10-70 µg/ml Cor.Coeff: L:0.996, E:0.999 L.O.D: L: 3 µg/ml, E: 3.5 µg/ml L.O.Q: L&E : 10 µg/ml.	2
3	Lamivudine, Tenofovir	Q-Analysis and UV	UV :(λmax) L: 271nm T: 260nm Q-Analysis: (Isobastic point) L:269nm T:260nm	Linearity: L:5-60µg/ml,T: 5-60µg/ml Corelation coefficient: L: 0.999, T:0.999 Regression equation: L: y= 0.0175+0.0038 T: y= 0.0239+0.0057 LOD:(µg/ml) L:0.239, T:0.472 LOQ:(µg/ml) L:0.791, T:1.56 Percent recovery: L:99.86, T:99.83	3
4	Lamivudine and zidovudine	UV AND Q-Analysis	UV:(λmax) L:273.2nm Z:267.3nm Q-Analysis: (Isobastic point) L:270.1nm Z:270.1nm	Linearity: L:4-12ppm, Z:4-12ppm Corelation coefficient: L:0.9997, Z:0.9994 Q-Analysis: L:0.9984, Z:0.9994 Regression equation:(λmax) L: y=0.0395x+0.0065 Z: y=0.0.0364x-0.0089 Iso absorptive point: L:y=0.04x-0.0022 Z:y=0.0354x-0.0078 Regression coefficient:(λmax) L:0.9994 , Z:0.999 Isoabsorptive point: L:0.998, Z:0.9989	4
5.	Lamivudine	UV	UV: λmax= 268nm	Linearity: 6-14µg/ml Recovery: 98.7, 101, 99.2% for three levels respectively. %RSD Precision: 0.62%	5

 

 

 

RP-HPLC method

S.NO	DRUGS	INSTRUMENTAL PARAMETERS	RESULTS OF VALIDATION	REFERENCE
6.	Lamivudine, zidovudine, nevirapine.	Column:Qualisil BDS C8 column(250mmX4.6mm i.d., 5µm particle size) Mobile phase:water and acetonitrile in the ratio of 70:30 v/v with pH 5 adjusted with acid Flow rate: 1 min/ml RT:  L: 3.1 min Z:4.4 min, N:7.0 min Detection : 250nm	Linearity:  L:1-15µg/ml, Z:3-24µg/ml, N:2.5-20µg/ml Corelationcoefficent: L:0.9992, Z:0.9992, N:0.9991 LOD: L:45ng/ml, Z:75ng/ml, N: 500ng/ml LOQ: L:150ng/ml, Z: 224ng/ml, N: 1550ng/ml. Plate count: L:12366 ,Z: 14803, N:16773.	6
7.	Lamivudine, zidovudine, nevirapine.	Column: Luna C18 150 X 4.6mm column. Mobile phase: 50mM ammonium acetate buffer(pH 6.8) and methanol. Gradient mode of elution with 0-35%v/v methanol for first ten minutes, increased to 50%v/v till 12 minutes and isocratic to 18 minutes, return to initial at 20 minutes. Flow rate: 1ml/min Detection:265nm	Linearity: It is linear over the following concentration range for five analytes: Cytosine and thymine (0.5-8µg/ml), 3TC (1-50µg/ml), AZT and NVP (1-80µg/ml). Coefficient of determination: >0.9997 Accuracy: (mean recovery        ± S.D) 101.26±1.27% Intraday precision: (%RSD) 0.49±0.28% Interday precision: (%RSD) 2.24±0.26%	7
8.	Lamivudine, Tenofovir Disoproxil Fumarate, Efavirenz	Column:kromasil C18analytical column(150X4.6mm, 5µm) Mobile Phase: 70 volumes of methanol and 30 volumes of 10mM phosphate buffer(pH  5.0) Flow Rate: 1min/ml RT: L:2.76,T:3.96,E:10.5	Linearity: L: 1-6µg/ml,T:1-6µg/ml, E:2-12µg/ml Recovery: L:99.46- 101.36% T:99,57-101.42% ,E: 99.96-100.87%	8
9.	Lamivudine, efavirenz	Column: Luna 5μ C18 (2) 100A (250 × 4.60 mm i.d) Mobile Phase: 0.1% triethylamine (pH adjusted to 5.11 with 0.1% orthophosphoric acid) and acetonitrile (30:70 % ) Flow Rate: 1min/ml RT: For lamivudine was 2.271±0.177 min and efavirenz was 7.267±0.513 min	Linearity: L:40-100µg/ml, E:10-80µg/ml. Corelation Coefficient: L:0.998, E:0.997 LOD:L:0.004µg/ml  ,E:0.02µg/ml LOQ:L:0.03µg/ml  ,E:0.07µg/ml Repeatability: L: 0.419, E: 0.297 Theoritical plates: L: 5177,  E: 11751 Tailing factor: L: 0.896,  E:1.132 Recovery (%) 50-     L:99.61,    E:99.66 100-   L:100.05,  E:99.70 150-   L:99.55,    E:99.45 Precision (%RSD) Inter Day(n=3) L:0.548, E:0.489 Intraday(n=3)L:0.301, E: 0.281	9
10.	Lamivudine, stavudine	Column: C18 45µ (250X4.6mm) Mobile Phase: Water : methanol in the ratio 90:10 Flow Rate: 1ml/min RT: S: 5.621 min, L: 4.176min	Linearity: L:20-100µg/ml, S:20-100µg/ml LOD:S:3.52µg/ml, L:0.825µg/ml LOQ:S:9.61µg/ml, L:2.501µg/ml. %RSD:S:0.43, L:0.26. Recovery:  L:99.32-101.36% S:99.32-101.36%	10
11.	Lamivudine, didanodine, efivirenz.	Column: Oyster BDS premium C18 (250mm X 4.6mm, 5µm) Mobile Phase: Water:tetrahydrofuran : acetonitrile (45.83: 20.83: 33.34% v/v/v) Flow Rate:1.15ml/min RT: L:2.01±0.003, D: 3.01 ± 0.001, E: 8.61±0.002	Linearity: L: 15-90µg/ml, D:12.5-75µg/ml, E:  30-180µg/ml Recovery: L:99.85%, D: 99.78%, E:99.94% LOD: L:0.61µg/ml, D:0.43µg/ml, E: 0.65µg/ml LOQ: L:1.85µg/ml, D:1.31µg/ml, E:1.97µg/ml	11
12	Lamivudine, Zidovudine	Column:Xterra column (150mm X 4.6mm) Mobile Phase:potassium dihydrogen phosphate: acetonitrile (55:45) At pH 3 Flow Rate:0.5ml/min RT:L:3.556,Z: 5.364	Recovery(%): L:100.8% ,Z:100.1% CorelationCoeffiecient: L:0.999, Z:0.999	12
13.	Lamivudine, TenofovirDisoproxil Fumarate.	Column: column-enable C18 G 5µM, 250X4.6mm Mobile Phase: methanol and water in the ratio 70:30 v/v pH-3.2 Flow Rate:1 ml/min RT:  L: 3.048min, T:5.354 min.	Linearity:  L:10-50µg/ml  ,T: 10-50µg/ml Correlation Coefficient: L: 0.9999, T:0.9999 LOD:L: 1.488341, T:3.552008 LOQ:L:4.510123, T:9.76366 Tailing factor: L: 1.2, T: 1.4 Theoretical plates: L:26478.23, T:5687.56 RSD: L:0.678299, T:424776	13
14.	Lamivudine, zidovudine.	Column: Inert silODS C18(250X4.6 mmI.D) 5µm Mobile Phase: Ammonium acetate buffer pH 4.0, Acetonitrile and THF in the ratio of 60:30:10 Flow Rate:1ml/min RT: L:3.793 min Z:2.547 Detection Wavelength:240nm	Linearity: L: 30-70µg/ml, Z: 60-140µg/ml LOD:  L:1.98µg/mlZ:3.39µg/ml LOQ: L:5.99µg/mlZ:10.27µg/ml Theoretical Plates: L:3250       Z:2320 Tailing Factor: L:1.725, Z:1.742	14
15.	Lamivudine, Zidovudine, Efavirenz	Column: Symmetry C18 (250X4.6 mm, 5µ) Mobile Phase:Methanol : Water(65:35) Flow Rate: 1ml/min RT: L:2.519, Z:3.015, E: 24.103mins	Corelation Coefficient: L:0.9997, Z:0.9997, E:0.9997 Tailing factor: L:1.25 ,Z:1.32 ,E:1.12 Theoretical plates: L:6615 ,Z:7512 ,E:4500 RSD(%) L:0.05 ,Z:0.04, E:0.26 R2: L:0.9995 ,Z:0.9994 ,E:0.9993	15
16.	Lamivudine, efavirenz, zidovudine.	Column:C18 (250 x 4.6mm; 5µ) Mobile Phase: Acetonitrile 0.2M, potassium dihydrogen orthophosphate buffer adjusted to pH 3.2 in the ratio of 30:70 v/v Flow Rate: 1min/ml RT: E:2.01 min, L:2.90 min, Z:7.52min,Detection: 275nm	Linearity:  E:75-450µg/ml, L:18.5-112.5µg/ml, Z:37.5-225µgml %RSD:  E:0.15%, L:0.24%, Z:0.37% LOD: E:20ng/ml, L:1ng/ml, Z:2ng/ml LOQ: E:50ng/ml, L:2.5ng/ml, Z:5ng/ml	16
17	Lamivudine, Tenofovir disproxil fumarate	Column:Inertsil ODS 3V, 250mmX4.6mm, 5µ) Mobile Phase:phosphate buffer and acetonitrile in the ratio of 55:45 v/vFlow Rate:1.2 ml/min RT:L:2.430, Z:4.550	Corelation coefficient: L:0.995 ,T:0.998 Recovery: L:98.48% ,T:98.64% Theoretical Plates: L:4278 ,T: 3675	17
18.	Lamivudine, Stavudine, Nevirapine	Column:Zorbax C8 ( 250mm X 4.6mm, 5µm) Mobile Phase: 0.1% OPA:Acetonitrile (50:50) Flow Rate: 1min/ml. RT:L:2.350,S:4.124, N: 11.234	Linearity: L: 37.5- 112.5µg/ml, S: 7.5-22.5µg/ml, N:50-150µg/ml. LOD:L:0.146, S:0.1705, N:1.215 LOQ:L:0.486, S:0.5682, N: 4.049 Theoretical plates: L: 4244, S:5330, N:7544 Tailing Factor: L:1.08, S:1.13, N:1.07 %RSD:L: 0.7, S:0.6, N:0.5	18
19.	Lamivudine, Zidovudine.	Column: C18 column, kromasil column, Hypersil BDS column. Mobile Phase:water : methanol in the ratio of 40:60 v/v Flow Rate: 0.8ml/min	Plate Count: L:7360.35, Z:7630.20 Tailing: L:1.22, Z:1.29	19
20.	Lamivudine, Tenofovir Disproxil Fumarate	Column: Thermo scientific Hypersil BDS 5µ C18 120A(250X4.60mm) Mobile Phase: Acetonitrile and phosphate buffer (80:20% v/v), pH 3.5 Flow Rate: 1.2ml/min RT: L: 2.33 min, T:2.68min	Linearity: L: 15-35µg/ml, T:15-35µg/ml Correlation Coefficient: L:0.999, T:0.999 LOD:(µg/ml)L: 0.4632, T:1.46 LOQ: (µg/ml)L:1.544, T:4.29 Theoretical Plates:L: 3369, T:3389 Tailing factor:L:1.220, T:1.230 %RSD:L:0.65 , T:0.715	20
21.	Lamivudine, abacavir, dolutegravir.	Column:Luna phenyl hexyl(250mm X 4.6mm, 5µm) Mobile Phase: Acetonitrile and 0.1M phosphoric acid buffer 50:50 v/v. Flow Rate: 1min/ml RT: L:3.3min,  A:4.5min D:6.3min Detection Wavelength: 258nm	Linearity: L: 3-45µg/ml, A:6-90µg/ml, D:0.5-7.5µg/ml. Correlation Coefficient: L:0.999, A:0.999, D:0.999. %Recovery: L:100.58, A:100.27, D:100.11 LOD:L:0.036µg/ml, A:0.065µg/ml, D:0.021µg/ml LOQ: L:0.112µg/ml, A:0.198µg/ml, D:0.071µg/ml. Intercept: L:3256, A:3006, D:536. Slope:L:74605, A:49626, D:61114.	21
22.	Lamivudine, Zidovudine	Column:Shiseido C18 column (250nmX4.6mm, 5µm particle size) Mobile Phase: phosphate buffer (pH 3) and CAN in the ratio of 70:30, v/v. Flow Rate: 1.0 min/ml RT:Z:3.721 min ,L:2.512 min Detection: 228nm	Linearity: L: 7.5-22.5µg/ml,  Z:15-45µg/ml Correlation Coefficient:0.999 % RSD: less than 2% Recoveries:L:99.06%, Z:99.88% LOD:L:0.1ng/ml, Z:0.1µg/ml LOQ:L:0.1µg/ml, Z:0.1µg/ml	22
23.	Abacavir, lamivudine, dolutegravir	Column:Inertsil ODS 250X 4.6 mm, 5µm. Mobile Phase: Buffer: Acetonitrile: Methanol in the ratio of 50:20:30%v/v. Flow rate: 1 min/ml Detection wavelength: 225nm RT: L:2.2min,A:2.9min, D:7.4min Column Temperature:300C	Linearity: L:15-90µg/ml, A:30-180µg/ml, D:2.5-15µg/ml Correlation Coefficient: L:0.9999, A:0.9998, D:0.9992. Recovery: L:100.04%,A:99.73%, D:100.29% LOD: L:0.10µg/ml, A:0.11µg/ml, D:0.06µg/ml LOQ:L:0.32µg/ml, A:0.33µg/ml, D:0.18µg/ml	23
24.	Lamivudine, efavirenz.	Column: ODS C18 column(256X4.6mm and 5µm)xterra Mobile Phase:30mm Ammonium acetate (ph=3): acetonitrile: methanol in the ratio of 50:30:20 Flow Rate: 1 min/ml RT:L:2.527 min, E:2.527 min Detection wavelength: 258nm.	Linearity: L:60-140µg/ml, E:60-140µg/ml Correlation Coefficient: L:0.999, E:0.999	24

 

In human plasma

S. No	DRUGS	METHOD	COLUMN, MOBILE PHASE, RT	RESULTS OF VALIDATION	REFERNCE
25.	Zidovudine, Lamivudine, Nevirapine	UV, HPLC in human plasma	Column:Hypersil BDS C18 column Mobile Phase: 0.1 M ammonium acetate buffer in 0.5% acetic acid, v/v and methanol(40:60, Flow Rate:0.85ml/min Run Time: 10 min Wavelength:270nm	Linearity: Z:50-3000, L:50-2000, N:10-3000ng/ml LOQ: Z: 50, L:50, N:10ng/ml	25
26.	Zidovudine, Lamivudine, Nevirapine.	LC-MS/MS in human plasma	Column: peerless basic C18 Mobile Phase:0.1% formic acid in water: methanol(15:85,v/v) Injection Volume:3µl Run Time:3.0min	Linearity: Z:5-1500ng/ml, L:5-1500ng/ml N:10-3000ng/ml Precision:1.6-10.1% Accuracy:93.8-110.8%	26
27.	Tenofovir, Lamivudine, Nevirapine	LC-MS/ MS in human plasma	Column: ProntosilC18AQ column Mobile Phase:1mM ammonium acetate in water: acetonitrile (50:50, v/v). pH: 6.5±0.3	Linearity: T:2-500 ng/ml, L: 10-4000ng/ml, N:10-4000ng/ml Recovery:61-85% %CV: less than 12.2% LLOQ,LQC,MQC,HQC was within +_8.5%	27
28.	Lamivudine	HPLC in human plasma	Column:chromolithrp—18e column Mobile phase:50mm sodium dihydrogen phosphate-triethylene(996.4, v/v) Flow rate: 1.5ml/min Column temperature: 200C	Linearity:40-2560 Corelation coefficient:0.999 LOD:10ng/ml LOQ:40ng/ml Recovery:97.7%	28

 

UPLC in rat plasma.

S. NO	DRUGS	METHOD	COLUMN ,MOBILE PHASE, RT.	RESULTS OF VALIDATION	REF
29.	Entecavir, Lamivudine	UPLC-MS/MS	Column: Hydrophilic interaction chromatography column(HILIC) Solid-phase extraction (SPE) cartridges were used to extract the analytes from rat plasma. A triple quadrupole mass spectrometer equipped with an electrospray ionization(ESI) was applied  to detect the drug.	Linearity: L:50-8000 ng/ml, E:0.5-80 ng/ml. LOQ: L:50 ng/ml,, E:0.5 ng/ml.	29

 

HPTLC

S. NO.	DRUGS	METHOD	COLUMN,  MOBILE PHASE, RT.	RESULTS OF VALIDATION	REF
30.	Lamivudine, tenofovir disproxil fumarate.	HPTLC	HPTLC silica gel 60F254 plates. Mobile Phase: 20ml of toluene and 10ml of methanol. RT: L:0.35 to 0.38, T:0.57 to 0.59mins.	Coefficient OfVariation: L:3.4% ,T:1.3% CV For Intermediate Precision: L:3.9% , T:3.8%. Analytical range: L: 2.000-3.100µg, T: 2.000-3.100µg.	30
31.	Lamivudine , Efavirenz	HPTLC	HPTLC plates pre-coated with silica gel 60G F254. Mobile Phase: Ethyl acetate: methanol: formic acid in the ratio of 7.0:2.5:0.5 (v/v).	Linearity: L:50-200ng/spot, E:100-400ng/spot Regression coeffiecient: L:>0.999, E:>0.999 %Rsd values: Interday and intra day: not more than 2.0	31

 

Micellar liquid chromatography (MLC)

S. No	DRUG	METHOD	COLUMN, MOBILE PHASE, RT	RESULTS OF VALIDATION	REF
32.	Lamivudine	Micellar liquid chromatography (MLC)	Column: C18 thermostated column at 300C. Mobile Phase: 0.15Msodium dodecyl sulphate(SDS)- 4%(v/v) 1-butanol- 0.01M KH2PO4-Na2HPO4 pH 7 with zidovudine as internal standard. Flow Rate: 1.0 ml/min Wavelength:272nm.	Linearity:r2>0.9996 LOD:1.6X10-7-6.9X10-7 M LOQ:1X10-5M Intra-Day Precision: 0.02-1.48% Inter-Day Precision: 0.04-1.66% Recoveries:92.9-199%	32

 

CWT And Derivative Transform Techniques.

S. NO	DRUG	METHOD	COLUMN, MOBILE PHASE, RT	RESULTS OF VALIDATION	REF
33.	Lamivudine, Zidovudine.	Continuous wavelet transform and derivative transform techniques.	Instrument:TheDaubechies (db5) wavelet family (242nm) and Dmey wavelet family (236nm) were found to give the best results under optimum conditions for simultaneous analysis of lamivudine and zidovudine respectively. Wavelength:L:266nm,Z: 248nm.	Recoveries: CWT: L:100.31%, Z:100.2%.   DS: L:99.42%, Z:97.37%	33

 

CONCLUSION:

This review is aimed at focussing the role of different analytical techniques used for the determination of  lamivudine including its determination in biological fluids. Though HPLC and HPTLC are the most preferred methods, UV methods are inexpensive and can be applied in routine analysis

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Accepted on 14.09.2018           © RJPT All right reserved

Research J. Pharm. and Tech 2018; 11(11): 5166-5172.