Review on Analytical Methods for Determination of Lamivudine, Dolutegravir and Tenofovir Disoproxil Fumarate in Fixed Dose Combination

Pharmaceutical medicines play an important role in human life that helps to cure different diseases. For the chemical and pharmaceutical analysis of the drug effective quality control and pharmacodynamic and pharmacokinetic studies are needed. Several methods have been developed and validated for its pharmaceutical and biological materials since it was introduced as an important antiretroviral agent. The literature survey reveals that only four RP HPLC method and one HPTLC was developed for the simultaneous estimation of Dolutegravir, Lamivudine and Tenofovir disoproxil fumarate in tablet dosage form. These three drugs are used as antiretroviral medicines which are used for HIV or AIDS prevention and treatment. The goal of this review is to define and establish a simple, precise and selective method for estimating the dosage of Lamivudine, Tenofovir Disoproxil fumarate and Dolutegravir in biological and pharmaceutical dosage form using the HPLC, HPTLC, UPLC, UV Visible spectroscopy, LC/MS, Infrared spectroscopy, NMR spectroscopy, Microbiological assay, Electrochemical studies and Capillary electrophoresis. UV-detector HPLC is commonly used in pharmaceuticals and LC-MS are widely used for biological materials with mass and tandem mass spectrometer detector systems. Various parameters such as device suitability, process accuracy, precision, linearity, detection limit will validate the UV Visible spectroscopy and RP-HPLC technique.

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METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LAMIVUDINE, DOLUTEGRAVIR AND TENOFOVIR DISOPROXIL FUMARATE IN BULK AND PHARMACEUTICAL DOSAGE FORM USING RP-HPLC AND ITS APPLICATION TO IN-VITRO DISSOLUTION STUDY

Journal of medical pharmaceutical and allied sciences ◽

10.22270/jmpas.v10i4.1165 ◽

2021 ◽

Vol 10 (4) ◽

pp. 3202-3207

Author(s):

K. Nihila

Keyword(s):

Tenofovir Disoproxil Fumarate ◽

Dosage Form ◽

Method Development ◽

In Vitro Dissolution ◽

Simultaneous Estimation ◽

Pharmaceutical Dosage Form ◽

Dissolution Study ◽

Rp Hplc ◽

Tablet Dosage

A simple, rapid, and economical method has been developed for the simultaneous estimation of the latest FDA approved antiviral drug combination, Dolutegravir, Lamivudine, and tenofovir disoproxil fumarate in tablet dosage form using Shimadzu LC-20 AT HPLC with a Phenomenex Luna column compartment., the method was developed using HPLC graded methanol with o-phosphoric acid as a mobile phase and successfully validated the developed method as per the ICH guidelines. The method was found to be linear, accurate, precise, robust, and rugged. The limit of detection and the limit of quantification was found to be 2.6μg/ml and 8.18μg/ml for Dolutegravir, 14.63 μg/ml and 44.35 μg/ml for Lamivudine and 16.43 μg/ml and 49.81 μg/ml for tenofovir disoproxil fumarate respectively. The retention time was found to be 3.0, 2.3 and 2.7 min for Dolutegravir, Lamivudine and tenofovir disoproxil fumarate respectively. All of assessed parameters complied with the acceptance criteria hence indicated the usefulness of the RP-HPLC method for the determination of assay and in-vitro dissolution study for tablet dosage form which contains lamivudine, tenofovir disoproxil fumarate, and dolutegravir active substances. Hence the method can be applied for routine quality control of the drugs.

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Novel RP-HPLC method development and validation for simultaneous estimation of metformin, voglibose and pioglitazone in bulk and triple fixed drug combinations pharmaceutical dosage form

Journal of Drug Delivery and Therapeutics ◽

10.22270/jddt.v9i1.2256 ◽

2019 ◽

Vol 9 (1) ◽

pp. 30-37

Author(s):

Mulchand A. Shende ◽

Balkrishna R Budde

Keyword(s):

Dosage Form ◽

Hplc Method ◽

Hypoglycemic Agents ◽

Fixed Dose ◽

Simultaneous Estimation ◽

Regression Equations ◽

Pharmaceutical Dosage Form ◽

Pharmaceutical Dosage Forms ◽

Rp Hplc ◽

Ich Guidelines

Reducing treatment complexity can be achieved through the use of single-tablet triple fixed-dose combinations of oral hypoglycemic agents. A simple, precise and accurate reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of Metformin (MET), Voglibose (VOG) and Pioglitazone (PIO) in pharmaceutical dosage forms. Chromatographic separation was achieved on an Younglin (SK) gradient System with UV 730 D detector and Cosmosil C18 (250 x 4.6 mm, 5μm) column, maintained at 45°C using 0.1% v/v acetonitrile: triethylamine (30:70, v/v), pH 2.5 with flow rate 0.8 ml/min with injection volume at 20 μl and wavelength ultraviolet detection at 232 nm. MET, PIO and VOG obey Beer–Lambert’s law over the concentration range of 200-600 µg/ml, 30-90 µg/ml and 0.08-0.24 µg/ml, respectively, with regression equations y=2.021x -186.7 (MET) (R2 = 0.998), y=9.876x-202.31 (PIO) (R2 = 0.999), and y= 502.3x-17.23 (VOG) (R2 = 0.999). % RSD and recoveries were 100.57-101.60 for MET, 99.79-102.61 for PIO and 100.02-101.05 for VOG indicate good accuracy of method. The marketed formulation analyzed using developed method and mean % amount were found 101.62, 100.38 and 98.75 for MET, PIO and VOG respectively with % RSD values NMT 2.0%. The developed spectrophotometric method can be employed for routine analysis of MET, VOG and PIO in bulk and tablet formulation. The developed RP-HPLC method was sensitive and selective for estimation of metformin, voglibose and pioglitazone in combined dosage form. The method was validated as per ICH guidelines. Keywords: RP-HPLC, ICH guidelines, Metformin, Voglibose, Pioglitazone, Validation

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