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 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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Original Article

Simultaneous estimation of dapagliflozin and linagliptin using reverse phase-HPLC with photo diode array (PDA)

J. Chem. Metrol. (2024) in press ; 1 - 11
by Anchal Shukla , Usmangani K. Chhalotiya , Dimal Shah , Jinal Tandel , Hetaben Kachhiya and Mital Parmar

Dapagliflozin inhibits selective sodium–glucose co-transporter-2 and Linagliptin competitively and reversibly inhibits dipeptidyl peptidase-4 in fixed dose Combination (1:1) is used in the treatment of Type 2 Diabetes Mellitus. For estimation Dapagliflozin and Linagliptin in bulk and Tablet formulation, an accurate and precise method using RP-HPLC was developed and validated. In the method being discussed here was optimized using Hypersil C18 (250 × 4.6 mm, 5 µm) column as Stationary Phase, Mobile Phase being used is Acetonitrile: Water (90:10) adjusting pH 3 using Ammonium Acetate. The Flow Rate was adjusted to 1ml/min. Both Dapagliflozin and Linagliptin (1:1) sample was detected at analytical wavelength of 244nm using Photo diode array detector. The Linearity Range was between Concentration of 0.1µg/ml to 20µg/ml with correlation Coefficient of 0.995 and 0.999 for Dapagliflozin and Linagiliptin Respectively.

DOI
http://doi.org/10.25135/jcm.104.2401.3020
Keywords
Diabetes Mellitus dapagliflozin linagliptin RP-HPLC method validation
Available online: February 14, 2024
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Original Article

Development and application of RP–HPLC method for estimation and evaluation of stability of brinzolamide in ophthalmic formulation

J. Chem. Metrol. (2024) in press ; 1 - 9
by Mehul Patel , Ritu Dwivedi , Umang Shah and Hetaben Kachhiya

This study outlines the development, optimization, and validation of a robust reverse-phase high-performance liquid chromatography (RP-HPLC) technique for the precise quantification of Brinzolamide in ophthalmic products, aligning International Council for Harmonization (ICH) guidelines. The method employed a Phenomenex (C18) (250×4.6mm) column with 5μm particle size as the stationary phase, a 1 mL/min flow rate for the mobile phase (composed of acetonitrile: water 35:65 v/v, pH adjusted to 3 with orthophosphoric acid), and detection at 254 nm. Under these conditions, Brinzolamide displayed Rt of 4.9 minutes. The validation process, following ICH standards, exhibited excellent linearity within the 5–30 μg/mL concentration range, with a limit of detection at 0.22 μg/mL and a limit of quantification at 0.67 μg/mL. Recovery rates from ophthalmic formulations fell between 98.3%-101.08%, indicating high accuracy. Accelerated stability assessments conducted over three months revealed content retention between 98.2%-100.9%, affirming the product's stability. Additionally, Brinzolamide withstood various stress conditions without interference in quantification, as the degradation products had distinct retention times from the pure drug, offering excellent resolution. In conclusion, this RP-HPLC method is suited for routine quality control analysis of Brinzolamide in commercial ophthalmic preparations, due to its specificity, accuracy, precision, and sensitivity, aligning perfectly with ICH guidelines.

DOI
http://doi.org/10.25135/jcm.2311.2949
Keywords
Brinzolamide RP-HPLC method accelerated stability study force degradation degradation products
Available online: January 11, 2024
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