Journal of Chemical Metrology

A scientific open access journal in the field of analytical chemistry and accreditation
Editor-in-Chief: Mustafa Özyürek
Editor-in-Chief: Ahmet C Goren
Book Review and Review Article Editor: John Warren

LATEST ARTICLES

Original Article

Development of liquid chromatographic (LC) method for simultaneous estimation of novel anti diabetic drug Evogliptin and Metformin

J. Chem. Metrol. (2024) in press ; 1 - 10
by Deepanti Gajjar and Dimalkumar A Shah

Evogliptin and Metformin are antidiabetic medications. Evogliptin works by increasing the release of insulin from the pancreas and decreasing the hormones that raise blood sugar levels. This reduces the fasting and post-meal sugar levels. Metformin works by lowering glucose production in the liver, delaying the absorption of sugar (glucose) from the intestines, and increasing the body's sensitivity to insulin. Accurate and precise high performance liquid chromatographic method has been developed for the estimation of Metformin and Evogliptin. Agilent C18 Column (250mm x 4.6mm, 5µm particle size) was used as stationary phase and methanol: 0.11% acetic acid in water (31: 69 % V/V) was used as mobile phase. The method was linear in the concentration range 50-250 µg/mL and 0.5 to 2.5 µg/mL of Metformin and Evogliptin respectively with a correlation coefficient of 0.999. The proposed method was validated with respect to linearity, accuracy, precision, and robustness as per International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use ICH Q2 (R2) guideline. The method was successfully applied for the analysis of Metformin and Evogliptin

DOI
http://doi.org/10.25135/jcm.108.2312.2989
Keywords
Metformin evogliptin design of experiment validation accuracy robustness
Available online: March 28, 2024
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Original Article

Novel analytical method development and validation for simultaneous estimation of curcumin, ascorbic acid and salicylic acid in bulk and its pharmaceutical formulation by RP-HPLC

J. Chem. Metrol. (2024) in press ; 1 - 9
by Manisha Jadav , Vandana Patel and Lalit Jha

A precise and specific reverse phase high-performance liquid chromatographic method has been developed and validated to quantify curcumin, ascorbic acid, and salicylic acid in both bulk and hydrogel. Utilizing a Hypersil BDS C18 column and an isocratic mode, the mobile phase comprised of a mixture of 0.1% orthophosphoric acid and acetonitrile (50:50 v/v). The calibration range spanned concentrations of 100 - 300 µg/mL for curcumin, 50 - 150 µg/mL for ascorbic acid and 50 - 150 µg/mL for salicylic acid. The specificity of the proposed method for estimating these compounds was established through chromatographic peak purity analysis. The limit of detection and the limit of quantification were found to be 18.54 µg/mL and 56.20 µg/mL for curcumin, 10.05 µg/mL and 30.46 µg/mL for ascorbic acid, and 11.39 µg/mL and 34.51 µg/mL for salicylic acid respectively. The accuracy of the method was demonstrated by recovering curcumin, ascorbic acid, and salicylic acid from the hydrogel formulation with a recovery rate exceeding 98%. This indicates the capability of the method to accurately estimate active pharmaceutical ingredients in hydrogel dosage form without interference from excipients. Validation results support the potential applicability of the proposed method for the quantitative estimation of these three drugs in hydrogel.

DOI
http://doi.org/10.25135/jcm.107.2310.2936
Keywords
High Performance liquid chromatography Hydrogel Method Development Curcumin Ascorbic acid Salicylic acid
Available online: March 15, 2024
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Original Article

RP-HPLC method combined with ultrafiltration for simultaneous analysis of Melphalan and Topotecan in human plasma samples

J. Chem. Metrol. (2024) in press ; 1 - 11
by Ozan Kaplan , Nergiz Yılmaz , Büşra Uçar , Merve Özge Algedik , İrem Koç , Hayyam Kıratlı and Mustafa Çelebier

Pharmaceutical analysis still attracts the attention of researchers, and pharmaceutical analysis methods specific to the purpose of the application are needed in routine applications. In this study, the RP-HPLC method was developed for the simultaneous analysis of two different cancer drugs from human blood plasma due to simultaneous use. Melphalan and topotecan are licensed drugs that have been used for a long time. In routine practice, the simultaneous use of these two drugs is limited. However, studies have found that two active substances were used together in high-dose chemotherapy applications. This situation encourages the development of methods for the simultaneous analysis of both active substances in spiked human blood plasma samples. In this study, melphalan and topotecan were analyzed by RP-HPLC in 17 minutes, including post-run, with a gradient elution program using a Superco 5 µm C18 100 Å LC Column (100 x 4.6 mm) when the flow rate was 1.0 mL min-1. The method was linear in the 1.0- 20.0 µg/mL range for both active substances. The detection wavelength was 261 nm. The accuracy and precision of the validated analytical method were demonstrated through intraday and interday studies. The analyte was freed from the remaining plasma components due to filtering the supernatant (after precipitation of the plasma proteins with methanol) with an ultrafilter (having 10 kDa pores). The simple methodology used in this study can be easily adapted to any pre-clinical or clinical application where analysis of melphalan and topotecan in plasma is required.

DOI
http://doi.org/10.25135/jcm.105.2311.2962
Keywords
Melphalan Topotecan RP-HPLC pharmaceutical analysis ultrafiltration validation
Available online: March 09, 2024
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Original Article

Development of an RP-HPLC method to evaluate the basic characteristics of talazoparib-loaded PLGA nanoparticles

J. Chem. Metrol. (2024) in press ; 1 - 9
by Beril Tas Topcu , Ozan Kaplan , Sibel Bozdağ Pehlivan , Mustafa Çelebier and Levent Öner

The use of poly (ADP-ribose) polymerase (PARP) inhibitors for cancer treatment has been reported previously. Talazoparib is a PARP inhibitor, and its solubility problems encouraged us to prepare talazoparib-loaded poly(lactic-co-glycolic acid) (PLGA) nanoparticles for use in brain cancer models. To determine the encapsulation efficiency and release profile, a reversed-phase high-pressure liquid chromatography (RP-HPLC) method was developed and validated. A Shiseido 5 µm C18 100 Å column (250 × 4.6 mm) was used with a flow rate of 1.0 mL/min. Isocratic elution was performed using an acetonitrile:phosphate buffer (100 mm, pH 6.25) (35:65 v/v) mixture. The injection volume was 5 μL and UV detection was performed at 227 nm. The method was linear within the range from 0.1 to 12.5 µg/mL. The encapsulation efficiency and release profile of the prepared formulation were analyzed using the developed RP-HPLC method, and it was found that the encapsulation efficiency was 65.17% ± 0.50 and the release of the talazoparib was around 40% within 5 h and remained stable for 25 h. The RP-HPLC method developed in the present study can be adapted for further applications to determine talazoparib in its commercial formulations and proposed encapsulated drug delivery systems.

DOI
http://doi.org/10.25135/jcm.2310.2937
Keywords
Talazoparib RP-HPLC nanoparticles drug delivery method development
Available online: February 24, 2024
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