Eco-friendly estimation of isosorbide dinitrate and hydralazine hydrochloride using Green Analytical Quality by Design-based UPLC Method

Chanduluru, Hemanth Kumar; Sugumaran, Abimanyu

doi:10.1039/d1ra04843k

Cited by 30 publications

(6 citation statements)

References 21 publications

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“…GAPI [ 45 , 46 ] is another qualitative method, used to measure the greenness based upon the stages involved in an analytical method. GAPI focuses on two aspects: (I) sample preparation and (II) instrumentation assessment.…”

Section: Resultsmentioning

confidence: 99%

Green Analytical Approach for the Determination of Zinc in Pharmaceutical Product Using Natural Reagent

Sharma

et al. 2022

International Journal of Analytical Chemistry

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A selective, sensitive, and environmentally safe spectrophotometry method was developed and validated for the determination of zinc in pharmaceutical substances using natural reagents obtained from the leaves of plant Acacia catechu. Different factors were optimized such as volume of reagent, selection of pH, and stability of the color complex. The drug showed a stable yellowish orange color complex at 550 nm. The greenness of the methods was estimated using an eco-scale tool where the presented method was found to be excellent green with an ecoscore of 84 based on spectrophotometric determination. Also, the greenness of the method was assessed by the Green Analytical Procedure Index and found to be eco-friendly. The method was validated in conformance with ICH guidelines, with acceptable values for linearity, accuracy, precision, LOD, and LOQ. The linearity range for zinc sulphate was 5–25 μg mL−1 with an R2 value of 0.996. The % RSD for intraday precision and interday precision was less than 2%. The suggested method can be employed for the economic analysis of zinc in its pure form and various formulations. The presented spectrophotometric method is the first analytical method for the analysis of zinc present in zinc sulphate and showed greater ecoscale as compared to the official method.

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Section: Resultsmentioning

confidence: 99%

Green Analytical Approach for the Determination of Zinc in Pharmaceutical Product Using Natural Reagent

Sharma

et al. 2022

International Journal of Analytical Chemistry

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“…A design of experiment-based robustness study was performed to determine the probability of risk or failure [29][30][31][32][33][34][35][36][37][38][39][40][41][42]. The critical analytical attributes (CAAs) are selected from the finalized method conditions, which significantly impact the separation of components, and verified against respective critical quality attributes (CQAs).…”

Section: Design Of Experiments Studymentioning

confidence: 99%

Development, stability‐indicating assessment, and evaluation of influential method conditions using a full factorial design for the determination of Nintedanib esylate‐related impurities

Yenda

Katari

Satheesh³

et al. 2023

J of Separation Science

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The design of an appropriate analytical method for assessing the quality of pharmaceuticals requires a deep understanding of science, and risk evaluation approaches are appreciated. The current study discusses how a related substance method was developed for Nintedanib esylate. The best possible separation between the critical peak pairs was achieved using an X-Select charged surface hybrid Phenyl Hexyl (150 × 4.6) mm, 3.5 μm column. A mixture of water, acetonitrile, and methanol in mobile phase-A (70:20:10) and mobile phase-B (20:70:10), with 0.1% trifluoroacetic acid and 0.05% formic acid in both eluents. The set flow rate, wavelength, and injection volumes were 1.0 ml/min, 285 nm, and 5 μl, respectively, with gradient elution. The method conditions were validated as per regulatory requirements and United States Pharmacopeia general chapter < 1225 >. The correlation coefficient for all impurities from the linearity experiment was found to be > 0.999. The % relative standard deviation from the precision experiments ranged from 0.4 to 3.6. The mean %recovery from the accuracy study ranged from 92.5 to 106.5. Demonstrated the power of the stabilityindicating method through degradation studies; the active drug component is more vulnerable to oxidation than other conditions. Final method conditions were further evaluated using a full-factorial design. The robust method conditions were identified using the graphical optimization from the design space.

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“…The primary purpose was to identify the method's sustainability, although five evaluation tools employed diverse methodologies or processes to analyze the method's greenness. Regardless of their tactics, all of the methodologies indicated that this technique is environmentally benign and flexible to future green assessment without any problems [35].…”

Section: Agree With Metricsmentioning

confidence: 99%

Eco-Friendly Analytical quality by design approach stability-indicating HPTLC technique for the quantitative evaluation of fluoxetine

PERUMAL¹,

KRISHNAN²,

K.S³

2023

jrp

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A design of experiments (DoE)-based quality by design (QbD) method was used to develop a stabilityindexing assay method in high performance thin layer chromatography (HPTLC) for the kinetic study of fluoxetine. This research proposes to use an environmentally friendly HPTLC technique based on Analytical Quality by Design (AQbD) to determine environmental friendliness. According to the literature, there is currently no published article on this method. A stationary phase consisting of TLC plates (Merck) pre-coated with silica gel 60F254 on aluminum sheets was used. A mobile phase of acetone: water with 1% orthophosphoric acid (8.5:1.5 v/v) was used. Central Composite Design (CCD) provides the opportunity to optimize the HPTLC separation and determine the parameters that have the greatest influence and those that have interactions. 20 optimized experimental runs were performed, including organic solvent content (A), saturation time (B), and driving distance (C). These 3 factors were evaluated for robustness, showing an insignificant effect on retention. The Rf value was 0.72±0.07, and the calibration curves were linear in the range of 0.3-5 mcg/point with regression coefficients r2 of 0.9987 for fluoxetine HCl. In the intraday and interday precision study, the percent RSD was 0.26 and 0.28, respectively. Fluoxetine was found to be highly susceptible to alkaline and acid hydrolysis compared to oxidation. All system suitability parameters were validated and were within the range specified in ICH guidelines. The novel method was also evaluated using four different approaches, including other evaluation methods: NEMI, GAPI, AGMS, AGREE, and it was found to be environmentally friendly.

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Eco-friendly estimation of isosorbide dinitrate and hydralazine hydrochloride using Green Analytical Quality by Design-based UPLC Method

Abstract: Analysing isosorbide dinitrate and hydralazine by using an eco-friendly method is an initial stepping stone towards environmentally benign method development, and its combination with the AQbD makes it the method to use for ages without revalidation.

Cited by 30 publications

References 21 publications

Green Analytical Approach for the Determination of Zinc in Pharmaceutical Product Using Natural Reagent

Green Analytical Approach for the Determination of Zinc in Pharmaceutical Product Using Natural Reagent

Development, stability‐indicating assessment, and evaluation of influential method conditions using a full factorial design for the determination of Nintedanib esylate‐related impurities

Eco-Friendly Analytical quality by design approach stability-indicating HPTLC technique for the quantitative evaluation of fluoxetine

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