AQbD Driven Development of an RP-HPLC Method for the Quantitation of Abiraterone Acetate for its Pharmaceutical Formulations in the Presence of Degradants

Jena, Bikash Ranjan; Panda, Siva Prasad; Kulandaivelu, Umasankar; Alavala, Rajasekhar Reddy; Rao, G. Sadasiva; Swain, Sanjit Kumar; Pattnaik, Gurudutta; Ghose, Debashish

doi:10.4274/tjps.galenos.2021.74150

Cited by 10 publications

(8 citation statements)

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“…(Vogt and Kord 2011;Peraman et al 2015b; Das and Maity 2017) As a result, using Quality by Design concepts towards the construction of analytical methods has become rather prevalent in order to achieve high robustness and superior method performance. (Monks et al 2012) In recent times, many analytical methods for single drug estimation (Alruwaili 2021;Jena et al 2021;Patel et al 2021;Srujani et al 2021;Wadhwa et al 2021) and simultaneous quantification (Gundala et al 2019;Saurabh Chaudhari et al 2022) have been developed using AQbD method. Analytical quality by design refers to the systematic and scientific creation and optimization of analytical procedures.…”

Section: Methods Development Incorporating Qbdmentioning

confidence: 99%

Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies

Kola¹,

Shanmugasundaram²

2023

PHAR

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Aim: The current project involves developing an RP-HPLC method for simultaneous quantification of Candesartan Cilexetil and Pioglitazone based on analytical quality by design (AQbD). Materials and methods: When analysed in the Design Expert application, the critical method parameters were systematically refined using Central Composite Design and contours were derived for significant variables. A contour plot has been used to discover the technique operable design region that governs response variation, which is then empirically tested. Results: Successful chromatographic separation of title analytes was achieved on kromasil C18 (150 × 4.6 mm, 5 µm) column at 30 °C with mobile phase comprising 60% 20 Mm Potassium dihydrogen orthophosphate and 40% acetonitrile (v/v), isocratic elution pattern, 0.9 mL/min flow rate, and UV detection at 220 nm. The linear model for Candesartan Cilexetil was from 4 to 24 µg/ mL and Pioglitazone at 7.5–45 µg/ mL, respectively. Conclusion: The method met all the ICH Q2 (R1) validation criteria. The current approach aided for analysing simultaneous drugs can be expanded into quantifying drugs in biological matrix predominance with maximum recovery.

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Section: Methods Development Incorporating Qbdmentioning

confidence: 99%

Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies

Kola¹,

Shanmugasundaram²

2023

PHAR

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“…The samples were centrifuged using a 12 0 micro-centrifuge (Remi motors, Mumbai, India) at a speed of 3000 rpm for fteen minutes in order to separate the colloidal silicon adsorbent particles. After the proper dilution, a Shimadzu 1800A UV-Visible spectrophotometer with a max 248 nm setting was used to analyses the supernatant [19][20][21].…”

Section: Characterization Of Solid Snedds Formulationsmentioning

confidence: 99%

“…Literature study demonstrates that limited research works have been carried out using QbD driven approach for this drug with SNEDDS. Low systemic availability is a result of poor solubility, pre-systemic clearance in the gastrointestinal mucosa, and/or hepatic rst-pass metabolism [19]. Overall, the study discovered that the biopharmaceutical performance and drug solubility of the chosen drug were greatly enhanced by using a solid self-nanoemulsifying formulation.…”

Section: Introductionmentioning

confidence: 99%

“…Telmisartan works by blocking the action of angiotensin, which widens blood vessels and decreases blood pressure. The parent drug, telmisartan, has a signi cant absolute bioavailability of about 23% [17][18][19]. Literature study demonstrates that limited research works have been carried out using QbD driven approach for this drug with SNEDDS.…”

Section: Introductionmentioning

confidence: 99%

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Quality by design enabled self-nano emulsifying drug delivery systems development for the oral delivery of telmisartan: Improvement of biopharmaceutical performance

Maharana

Swain²,

Mahapatra

et al. 2023

Preprint

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Purpose: To increase the drug's oral bioavailability, a self-nano emulsifying drug delivery system was designed using capmul MCM, labrasol, and tween-20 as the oil, surfactant, and co-surfactant, respectively. Oil and Smix were tested for pre-isotropic compatibility and optimization of the formulations by using DoE software. Dispersibility, self-emulsifying duration, mean globule size, and stability were determined by a heating-cooling cycle and phase separation. Methods: Self-nano emulsifying systems were created into free-flowing granules by adsorbing using the ratios of aerosil 200, sylysia 350, 550, and 730 as porous carriers and neusilin as an adsorbing agent. The FT-IR study assessed the drug's compatibility with various excipients and confirm no interaction. The produced granules were analyzed using differential scanning calorimetry, dissolution profile, and other flow property measures. The SEM examination revealed no evidence of drug precipitation on the carrier's surface. Self-nano emulsifying tablets were prepared through direct compression and changed by adding hydrophilic polymers like Avicel 112 and cross-povidone. Results: The tablets produced had a round form, a pleasing appearance, less friability, and a faster rate of disintegration. The X-RD was used to characterize the physical properties of the pure drug and S-SEDDS, which determined that both the pharmaceutical and formulations were amorphous. Comparative dissolving testing with capsules in SGF pH 1.2 and phosphate buffer pH 6.8 revealed a significant increase in drug dissolution over the pure drug. Conclusion: The study signifies the chosen drug using S-SEDDS improved its biopharmaceutical performance significantly, which may be relevant to other drugs with similar properties.

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“…The calibration plots were constructed between concentrations versus peak areas and the linearity was found in the range from 2µg/ml to 10 µg/ml. The regression equation and correlation coefficient were calculated [13,14].…”

Section: Linearitymentioning

confidence: 99%

Development and validation of stability indicating RP-HPLC method for the estimation of azilsartan in Bulk

Mounika¹,

Nageswarrao²,

Kumari³

et al. 2022

ijhs

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Angiotensin-receptor blockers are often considered adequately efficacious in reducing blood pressure. By accepting the current regulatory requirements for an analytical method development, a reversed phase high performance liquid chromatographic method for routine analysis of Azilsartan has been developed. The optimized method was achieved using unisol C-18 (3μm, 4.6×150mm) coloumn with mobile phase consisting of mixture acetonitrile and methonal (90:10v/v) with a flow rate of 0.8ml/min at 249nm. The Linear concentration range is 2-10μg/ml. The detection and quantitation limit was found to be 0.45μg/ml. And the detection limit was found to be 0.149μg/ml. There are no interfering peaks under performed degradation conditions. The optimized method was validated according to ICH guidelines.

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AQbD Driven Development of an RP-HPLC Method for the Quantitation of Abiraterone Acetate for its Pharmaceutical Formulations in the Presence of Degradants

Cited by 10 publications

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Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies

Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies

Quality by design enabled self-nano emulsifying drug delivery systems development for the oral delivery of telmisartan: Improvement of biopharmaceutical performance

Development and validation of stability indicating RP-HPLC method for the estimation of azilsartan in Bulk

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AQbD Driven Development of an RP-HPLC Method for the Quantitation of Abiraterone Acetate for its Pharmaceutical Formulations in the Presence of Degradants

Cited by 10 publications

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﻿Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies

﻿Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies

Quality by design enabled self-nano emulsifying drug delivery systems development for the oral delivery of telmisartan: Improvement of biopharmaceutical performance

Development and validation of stability indicating RP-HPLC method for the estimation of azilsartan in Bulk

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Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies

Analytical quality by design-based RP-HPLC method for quantification of pioglitazone and candesartan cilexetil in bilayer tablet and its forced degradation studies