Analytical Techniques for the Analysis of Lopinavir and Ritonavir in Pharmaceutical Dosage Form and Biological Matrices: A Review

2021 ◽  
Vol 18 ◽  
Author(s):  
Mohammad Amir ◽  
Puneet Narula ◽  
Farzana Bano

Background: Lopinavir and Ritonavir are the protease inhibitor type of anti-retroviral drugs. Both are used for the treatment of HIV/AIDS. This paper reviews many analytical methods for the analysis of LPV and RTV in pharmaceutical formulations (tablet, capsule, syrup, and bulk) and biological fluids (human plasma, serum, cerebrospinal fluid, rat plasma, and human hair). Objective: The study aims to summarize various ana¬lytical techniques, such as Chromatography, Spectrophotometry; and also hyphenated techniques, such as LC-MS/MS, UPLC-MS for analysis of Lopinavir and Ritonavir. Method: The review deals with com¬prehensive details about the type of various analytical techniques, such as spectroscopy (UV), chromatography (RP-HPLC, HPTLC, UPLC), and hyphenated techniques, i.e., LC-MS/MS, UPLC-MS for the analysis of lopinavir and ritonavir. These techniques are either explored for the quantification, de¬tection of metabolite or for stability studies of the LPV & RTV. Conclusion: The present studies revealed that the HPLC technique along with the spectro-scopic, have been most widely used for the analysis. Out of the developed methods, hyphenated UPLC-MS and LC-MS are very sensitive and helps in the easy estimation of drugs compared to that of the other techniques. This review may provide comprehensive details to the researchers working in the area of analytical research of LPV & RTV.

2006 ◽  
Vol 89 (6) ◽  
pp. 1565-1572 ◽  
Author(s):  
Mohamed Walash ◽  
Fathalla Belal ◽  
Nahed El-Enany ◽  
Amina Abdelsalam

Abstract A highly sensitive spectrofluorometric method was developed for the determination of verapamil hydrochloride (VP HCl) in pharmaceutical formulations and biological fluids. The proposed method is based on investigation of the fluorescence spectral behavior of VP HCl in micellar systems, such as sodium dodecyl sulfate (SDS) and β-cyclodextrin (β-CD). In aqueous solutions of borate buffer of pH 9 and 8.5, VP HCl was well incorporated into SDS and β-CD, respectively, with enhancement of its native fluorescence. The fluorescence was measured at 318 nm after excitation at 231 nm. The fluorescence intensity enhancements were 183 and 107% in SDS and in β-CD, respectively. The fluorescence-concentration plots were rectilinear over the range of 0.020.2 and 0.020.25 μg/mL, with lower detection limits of 5.58 × 103 and 3.62 × 103 μg/mL in SDS and β-CD, respectively. The method was successfully applied to the analysis of commercial tablets and the results were in good agreement with those obtained with the official method. The method was further applied to the determination of VP HCl in real and spiked human plasma. The mean % recoveries in the case of spiked human plasma (n 4) was 92.59 3.11 and 88.35 2.55 using SDS and β-CD, respectively, while that in real human plasma (n 3) was 90.17 6.93 and 89.17 6.50 using SDS and β-CD, respectively. The application of the method was extended to the stability studies of VP HCl after exposureto ultraviolet radiation and upon oxidation with hydrogen peroxide.


2010 ◽  
Vol 46 (3) ◽  
pp. 375-391 ◽  
Author(s):  
Eric de Souza Gil ◽  
Giselle Rodrigues de Melo

Given the increasing demand for practical and low-cost analytical techniques, biosensors have attracted attention for use in the quality analysis of drugs, medicines, and other analytes of interest in the pharmaceutical area. Biosensors allow quantification not only of the active component in pharmaceutical formulations, but also the analysis of degradation products and metabolites in biological fluids. Thus, this article presents a brief review of biosensor use in pharmaceutical analysis, focusing on enzymatic electrochemical sensors.


Author(s):  
SK MANIRUL HAQUE ◽  
MURAD ALSAWALHA

Amlodipine is the best-prescribed medication for cardiovascular disease major risk factor for hypertension and atorvastatin well known for diabetic. First discussed low cost ultraviolet-visible technique for the determination and quantitation of drugs in pharmaceuticals and biological fluids. Chromatographic techniques have an application with respect to trace analysis. Different types of chromatography such as high-performance liquid chromatography, high performance thin layer chromatography have most frequent applications in the field of pharmaceutical as well as biomedical analyses. Chromatography combined with mass spectrophotometry has the ability to collect molecular ion, followed to prepare a spectrum to assess molecular weight as well as structure. High-performance liquid chromatography coupled with mass spectrophotometry is a reliable and dynamic technique for the analysis of small and large drugs molecule. The advantages and disadvantages of all techniques are compared with each other with respect to sensitivity, reproducibility and other important parameters. The investigation also focused for the quantitation on both drugs in pharmaceutical preparations and plasma samples with the help of all available analytical techniques.


Author(s):  
Parikela vani

A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Tenofovir Disoproxil Fumarate and Emtricitabine in pharmaceutical dosage form. Chromatographic separation of Tenofovir Disoproxil Fumarate and Emtricitabine was achieved on Waters Alliance -2695, by using Luna C18 (250mm x 4.6mm, 5µm) column and the mobile phase containing 0.1% TEA adjusted pH-2.5 with OPA & ACN in the ratio of 60:40 v/v. The flow rate was 1.0 ml/min, detection was carried out by absorption at 261 nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Tenofovir Disoproxil Fumarate and Emtricitabine were NLT 2000 and should not more than 2 respectively. The linearity of the method was excellent over the concentration range 30-450 µg/ml and 20-300 µg/ml for Tenofovir Disoproxil Fumarate and Emtricitabine respectively. The correlation coefficient was 0.999. % Relative standard deviation of peak areas of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Tenofovir Disoproxil Fumarate and Emtricitabine study of its stability.


Author(s):  
R Sireesha ◽  
P Syam Vijayakar ◽  
V Pavan Kumar ◽  
B Sivagami ◽  
Pranabesh Sikdar ◽  
...  

In the present work RP-HPLC method has been developed for the quantitative estimation of Terbinafine hydrochloride in bulk drug and pharmaceutical formulations. A rapid and sensitive RP-HPLC Method with PDA detection (220 nm) for routine analysis of in Bulk drug and Pharmaceutical formulation was developed. Chromatography was performed with mobile phase containing a mixture of Potassium dihydrogen phosphate and Acetonitrile (65:35 v/v) with flow rate 1.5 ml/min. The linearity was found to be in the range of 50-150 µg/ml with (r2=0.999). The proposed method was validated by determining sensitivity, accuracy, precision, LOD, LOQ and system suitability parameters according to ICH guidrelines.


Author(s):  
Vaishnavi Aher ◽  
S. D. Mankar ◽  
G. S. Shinde

Vildagliptin is approved by USFDA in 2007. Vildagliptin s- l-[n-(3-hydroxy-1-adamantyl) glycyl] pyrrolidine-2- carbonitrile is associate degree oral antihyperglycaemic agent (anti-diabetic drug) of the new dipeptidyl peptidase-4 (dpp-4) substance category of medicine. The present work categorical the new easy, accurate, precise analytical methodology for the determination of vildagliptin in bulk and pharmaceutical indefinite quantity kind. Analytical techniques play a decisive role by providing solutions like improvement. This paper could be a review and classification of the various analytical techniques that are the foremost widely-used in determination common provision issues. Pharmaceutical analysis plays an awfully outstanding conspicuous role in quality assurance similarly as internal control of bulk medication and pharmaceutical formulations. Fast increase in pharmaceutical industries and production of drug in numerous components of the globe has brought an increase in demand for brand new analytical techniques within the pharmaceutical industries. As a consequence, analytical methodology development has become the essential activity of study. Recent development in analytical ways has been resulted from the advancement of analytical instruments.


2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Farhan Ahmed Siddiqui ◽  
Nawab Sher ◽  
Nighat Shafi ◽  
Alisha Wafa Sial ◽  
Mansoor Ahmad ◽  
...  

RP-HPLC ultraviolet detection simultaneous quantification of piracetam and levetiracetam has been developed and validated. The chromatography was obtained on a Nucleosil C18 column of25 cm×0.46 cm, 10 μm, dimension. The mobile phase was a (70 : 30 v/v) mixture of 0.1 g/L of triethylamine and acetonitrile. Smooth flow of mobile phase at 1 mL/min was set and 205 nm wavelength was selected. Results were evaluated through statistical parameters which qualify the method reproducibility and selectivity for the quantification of piracetam, levetiracetam, and their impurities hence proving stability-indicating properties. The proposed method is significantly important, permitting the separation of the main constituent piracetam from levetiracetam. Linear behavior was observed between 20 ng/mL and 10000 ng/mL for both drugs. The proposed method was checked in bulk drugs, dosage formulations, physiological condition, and clinical investigations and excellent outcome was witnessed.


Author(s):  
Akshay P. Rote ◽  
Janardan Alhat ◽  
Amol A. Kulkarni

The day by day new combinations drugs are being introduced in market. Then the multiple therapeutic agents which acts at different sites are used in the management of various diseases and disorders are done. Thus it is necessary to develop methods for analysis with the help of number of analytical techniques which are available for the estimation of the drugs in combination. The analyst were determine the Specific, accurate, simple, selective and stability-indicating RP-HPLC method is developed and validated for simultaneous determination of sofosbuvir and ledipasvir in tablet dosage form. RP-HPLC method was performed on the systronics isocratic HPLC System equipped with SP930 D HPLC pump and dual wavelength UV-VIS detector and C18 column (250 mm × 4.6 mm, 5μm), using the mobile phase (Methanol: Water 83:17 v/v) pH 3.0 with 0.05% acidic acid at a flow rate of 1.0 ml/min, injection volume 20μl and UV detection at 245 nm. This method is validated according to BP, USP and ICH requirements for new methods, which include accuracy, precision, robustness, ruggedness, lod, loq, linearity and range. Linear relationships were obtained in the ranges of 10-50μg/ml and 40-200μg/ml with correlation coefficients of 0.9991 and 0.9994 at Rt value of 7.45 min and 3.50 min for sofosbuvir and ledipasvir respectively. The forced degradation studies as acidity, alkalinity, oxidation and hydrolytic degradation were performed according to ICH guidelines.


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