Log in

Relevant bibliographies by topics / ICH Q2 (R1); Recovery

Contents

Journal articles
Book chapters

Academic literature on the topic 'ICH Q2 (R1); Recovery'

Author: Grafiati

Published: 4 June 2025

Last updated: 1 August 2025

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the lists of relevant articles, books, theses, conference reports, and other scholarly sources on the topic 'ICH Q2 (R1); Recovery.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Journal articles on the topic "ICH Q2 (R1); Recovery"

1

B, Deshmukh S., Wagh P. A, Yadav S. S, and Mane M. B. "Stability-Indicating HPLC Method Development and Validation for the Simultaneous Determination of Vildagliptin and Dapagliflozin in Pharmaceutical Dosage Form." INTERNATIONAL JOURNAL OF DRUG DELIVERY TECHNOLOGY 14, no. 03 (2024): 1599–603. http://dx.doi.org/10.25258/ijddt.14.3.49.

Full text

Abstract:

Vildagliptin (VD) and Dapagliflozin (DP) were determined simultaneously by RP-HPLC using an ultraviolet (UV) detector, a Hypersil Gold C18 (250 × 4.6 mm) column, 5 µm and a mobile phase of acetonitrile: water (adjusted with O-Phosphoric acid to pH 3) in ratio 40: 60% v/v. The estimation wavelength was chosen to be 213 nm. VD and DP were shown to have retention times of 2.9 and 8.3 minutes, respectively. Q2 (R1) ICH guidelines were followed during the validation process. VD and DP correlation coefficient R2 values are 0.9993 and 0.999, respectively. While DP’s linearity range is 1 to 6 µg/mL, V

APA, Harvard, Vancouver, ISO, and other styles

2

K, Swamy Sekhar, Venkata kishore Ch, Tejeswara Rao V, and Raghu Babu K. "HPLC method for the development and validation of busulfan in pharmaceutical formulation." GSC Advanced Research and Reviews 6, no. 3 (2021): 136–42. https://doi.org/10.5281/zenodo.4644190.

Full text

Abstract:

A validated HPLC method was developed for the determination of Busulfan (BUS) in pharmaceutical formulation.It is a new simple, accurate, precise and reproducible HPLC method has been developed for the estimation of Busulfan (1,4-butanediol dimethanesulfonate) in its inject able dosage.The method developed in High Performance Liquid Chromatographic method using suitable column (YMC Pack ODS-A (150 x 4.6) mm, 3µm). All the components of the system are controlled using SCL-10Avp System Controller. Data acquisition was done using LC Solutions software.The method was validated as per the ICH

APA, Harvard, Vancouver, ISO, and other styles

3

Kumar, Sunil, and Bigan Ram. "Analytical method development and validation of L-Carnitine L-Tartarate in Pharmaceutical Dosage forms (Multivitamin tablets) using non aqueous titration." Journal of Drug Delivery and Therapeutics 9, no. 4 (2019): 588–90. http://dx.doi.org/10.22270/jddt.v9i5.3591.

Full text

Abstract:

The Non aqueous titration method was developed for quantitave analysis of L- Carnitine L-Tartarate in multivitamin tablets. The Non aqueous titration method was carried out using 0.1 N Perchloric acids. The present analytical method was validated according to ICH guidelines (ICH,Q2(R1)). The calibration curve was found to linear with correlation coefficient (r2=0.99995), Bias (-0.35) in the range of 50 to 150 % of standard solution. The precision and recovery were determined and all the parameter value found within acceptance limit. The value for both method and intermediate precision were fou

APA, Harvard, Vancouver, ISO, and other styles

4

T., S. Kamble. "High Performance Thin Layer Chromatography: Method Development and Validation for Estimating the Gallic Acid from Syzygium Cumini Seeds." International Journal of Pharmacy and Biological Sciences (IJPBS) 13, no. 3 (2023): 191–200. https://doi.org/10.5281/zenodo.10648678.

Full text

Abstract:

AbstractIn the current research work, an effective, efficient, exact, easy-to-follow, and trustworthy method was developed for the estimation of gallic acid content from Jamun seed powder. In this research, HPTLC technique is used for analysis along with other quality control test parameters. The preliminary studies by virtue of solubility studies, FT-IR spectroscopy, melting point determination, etc. Working wavelength was determined by UV-Visible spectroscopy. The analytical method development was done for gallic acid estimation in Jamun seed powder, using HPTLC following its validation usin

APA, Harvard, Vancouver, ISO, and other styles

5

Banothu, Bhadru* Tadikonda Rama Rao Arukala Bhavani. "Stability Indicating Analytical Method Development And Validation Of Carbamazepine Using UV Spectroscopy." International Journal in Pharmaceutical Sciences 2, no. 9 (2024): 1374–80. https://doi.org/10.5281/zenodo.13851427.

Full text

Abstract:

A novel Spectrophotometric method for quantifying carbamazepine in pharmaceuticals has been developed and validated per ICH Q2 (R1) guidelines. The maximum absorption wavelength was identified at 285 nm in a 0.1N NaOH solution, with a regression coefficient of 0.999, confirming adherence to Beer's Law within a 2–10 μg/ml concentration range. Calibration curves demonstrated linearity, and quality control standards showed accuracy, precision, and robustness, with recovery percentages between 99.2% and 100.8%. The method exhibited low relative standard deviation (RSD) values, with intra-

APA, Harvard, Vancouver, ISO, and other styles

6

Mangal, B. Gahandule* Shanker M. Dhobale1. "ESTIMATION OF HYDROCHLOROTHIAZIDE IN BULK AND TABLET DOSAGE FORMS BY AREA UNDER CURVE SPECTROPHOTOMETRIC METHOD." INDO AMERICAN JOURNAL OF PHARMACEUTICAL RESEARCH 07, no. 01 (2017): 7420–25. https://doi.org/10.5281/zenodo.1006947.

Full text

Abstract:

A simple, accurate and precise area under curve method was developed for spectrophotometric estimation of hydrochlorothiazide in pure and tablet dosage forms. “The area under two points on the mixture spectra is directly proportional to the concentration of the component of interest” is the AUC curve. The area selected for estimation of hydrochlorothiazide was between 260 to 280 nm. The method represented regression coefficient (R2 = 0.999) at concentration rang 5-25 μg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the hydrochlorothi

APA, Harvard, Vancouver, ISO, and other styles

7

Gaikwad, Pranjal, and Vijaya Barge. "Analytical Method Development and Validation of RP-HPLC Method for Estimation of Favipiravir in Bulk and Pharmaceutical dosage form." Journal of Neonatal Surgery 14, no. 32S (2025): 4520–29. https://doi.org/10.63682/jns.v14i32s.8145.

Full text

Abstract:

Objective: To develop and validate a simple, accurate, and cost-effective RP-HPLC method for the estimation of Favipiravir in bulk and pharmaceutical dosage forms. Methods: An RP-HPLC method was developed using a C18 column with methanol:water (35:65, v/v) as the mobile phase, pH 3.0, flow rate 0.8 mL/min, and UV detection at 225 nm. The method was validated as per ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, LOD, LOQ, and robustness. Forced degradation studies were conducted as per ICH Q1A(R2). Results: Favipiravir showed a retention time of 6.62 min. The method was

APA, Harvard, Vancouver, ISO, and other styles

8

M., M. Eswarudu* P. Srinivasa Babu P. Siva Krishna G. Sneha Latha N. Anusha M. S. K. Mounika and N. Punna Reddy. "METHOD DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHODS FOR THE ESTIMATION OF DARUNAVIR IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES 05, no. 04 (2018): 2230–37. https://doi.org/10.5281/zenodo.1215687.

Full text

Abstract:

Two simple, precise and economical UV Spectrophotometric methods have been developed for the estimation of Darunavir ethanolate (DRV) in bulk and its pharmaceutical dosage form. Two methods were developed based on measurement of absorption at maximum wavelengths, for Method Ⅰ 272.1 nm and Method ⅠⅠ 272.4 nm. Linearity for detector response was observed in the concentration range of 2-10 μg/ml for the both methods. The developed methods were validated with respect to linearity, accuracy (recovery), precision and specificity. The accuracy of the methods was assessed by recovery studies and wa

APA, Harvard, Vancouver, ISO, and other styles

9

K. Koradia, Shailesh, Dhwani R. Patel, Prachi A. Rana, Binny A. Rudani, and Unnati S. Chaudhari. "SPECTROPHOTOMETRIC DETERMINATION OF ANTINEOPLASTIC DRUG GEFITINIB IN TABLET DOSAGE FORM USING INORGANIC SOLVENT." Indian Drugs 59, no. 12 (2022): 79–81. http://dx.doi.org/10.53879/id.59.12.13081.

Full text

Abstract:

In the present research work, a simple, accurate and precise spectrophotometric method has been developed for the determination of gefitinib in bulk and its tablets dosage form. Gefitinib was dissolved in 0.1 N hydrochloric acid and absorbance was measured at 252.0 nm. The calibration curve obeyed Beer’s law in the concentration range of 3-15 µg mL-1 with correlation co-efficient of 0.9989. The detection limits and quantitation limits were found to be 0.69 µg mL-1 and 2.08 µg mL-1, respectively. The recovery ranged between 98.00 and 101.89 %. The validation parameters such as accuracy, precisi

APA, Harvard, Vancouver, ISO, and other styles

10

Mali, Rushikesh, and Tabassum Khan. "ANALYTICAL UV SPECTROSCOPY METHOD DEVELOPMENT AND VALIDATION STUDIES FOR SIMULTANEOUS ESTIMATION OF METFORMIN HCL AND QUERCETIN." INDIAN DRUGS 60, no. 11 (2023): 82–87. http://dx.doi.org/10.53879/id.60.11.14088.

Full text

Abstract:

In the current investigation, we have designed and assessed a simple and swift analytical approach employing UV spectroscopy for the simultaneous quantification of the analytes metformin and quercetin with excellent precision and accuracy. The wavelengths of interest are the wavelengths at which both the drugs show maximum absorbance: 233 nm for metformin and 256 nm for quercetin. Linearity study, conducted in methanol and phosphate buffer, yielded a correlation coefficient (r2 ) of 0.99. The validation study for the developed method was conducted in accordance with ICH Q2 R1 guidelines. The p

APA, Harvard, Vancouver, ISO, and other styles

More sources

Book chapters on the topic "ICH Q2 (R1); Recovery"

1

Borman, Phillip, and David Elder. "Q2(R1) Validation of Analytical Procedures." In ICH Quality Guidelines. John Wiley & Sons, Inc., 2017. http://dx.doi.org/10.1002/9781118971147.ch5.

Full text

APA, Harvard, Vancouver, ISO, and other styles

2

Kasangaki, Wilberforce. "Method Validation and Verification." In Analytical Methods for Drug Development. THINKPLUS PHARMA PUBLICATIONS, 2025. https://doi.org/10.69613/28x3yy16.

Full text

Abstract:

Method validation establishes analytical procedure reliability through systematic performance evaluation. ICH Q2(R1) guidelines provide validation frameworks adaptable across development phases from early research through commercialization. Risk-based approaches align validation effort with method purpose and product criticality. Validation parameters include specificity testing against potential interferents, linearity across concentration ranges, accuracy through recovery studies, precision at repeatability and intermediate levels, detection and quantitation limit determination, and robustne

APA, Harvard, Vancouver, ISO, and other styles

3

"Method Validation and Documentation (Procedure 5)." In SIFT-MS. Royal Society of Chemistry, 2025. https://doi.org/10.1039/9781837677917-00281.

Full text

Abstract:

As a chromatography-free analytical technique, selected ion flow tube mass spectrometry (SIFT-MS) speciates and quantifies volatile compounds in the gas phase using a very different approach to traditional laboratory techniques. Nevertheless, as described in this chapter, guidelines for analytical method validation, such as ICH Q2(R1), are readily adapted to both automated headspace-SIFT-MS analysis and less conventional SIFT-MS approaches. Additionally, recommendations are made for documentation of SIFT-MS methods for quality systems and routine use.

APA, Harvard, Vancouver, ISO, and other styles

4

Ranjith, K., D. Rama Sekhara Reddy, and TEGK Murthy. "Development and Validation of Stability Indicating Related Substances Method for Montelukast Sodium and Levocetirizine Dihydrochloride Combined Tablets by RP-HPLC." In Current Trends in Drug Discovery, Development and Delivery (CTD4-2022). Royal Society of Chemistry, 2023. http://dx.doi.org/10.1039/9781837671090-00304.

Full text

Abstract:

In this paper authors presented the development and validation of RP-HPLC method for determination of related substances present in Montelukast sodium and Levocetirizine dihydrochloride combined tablets. Chromatographic separation was achieved on Hypersil ODS (150 x 4.6 mm),5 µ column with flow rate 1 mL/min, detection wavelength 238 nm, injection volume 10 µL, column temperature 40°C and run time 75 mins. Gradient programming was used with mobile phase-A (MP-A)-50mM acetate buffer pH 5.5 and mobile phase-B(MP-B)-methanol: MP-A (90:10 %v/v). Developed method was validated as per ICH Q2(R1) gui

APA, Harvard, Vancouver, ISO, and other styles

We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!