Method Development and Validation of Analytical Procedures

Kalra, Kapil

doi:10.5772/19894

Cited by 13 publications

(9 citation statements)

References 13 publications

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“… The variance and standard deviation of the response, denoted as σ, and the slope of the calibration curve, denoted as S, are important variables in this context.  The value of S can be determined by utilizing the calibration curve of the analyte [33].…”

Section: Limit Of Quantitationmentioning

confidence: 99%

Review on method development and validation for different pharmaceutical dosage form

Vaishnawi R. Bhagwat,

Chetan M. Jain,

Nitin I. Kochar

et al. 2024

GSC Biol. Pharm. Sci.

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Pharmaceutical analysis is crucial for bulk and formulation quality control. Due to global medication manufacturing and pharmaceutical sector expansion, innovative analytical methods are in demand. Developing analytical procedures is now the most significant part of analysis. Improvements in analytical instruments have led to new analytical methods. The improvement of analytical methodologies and technologies has reduced analysis time, increased precision and accuracy, and decreased analysis costs. As a consequence, the majority of pharmaceutical businesses are investing heavily in specialist analysis labs. Analytical techniques for active pharmaceutical ingredients (API), excipients, drug products, degradation products and related substances, residual solvents, and other chemicals are created and verified. As a consequence, it has become an essential component of the regulating organization's standards. Development of analytical methodologies leads to official test methods. Quality control labs utilize these methods to verify drug identity, purity, safety, effectiveness, and performance. Production analytical methods are becoming relevant to regulators. Regulatory agencies expect applicants to demonstrate control of the drug development process using established analytical methodologies.

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Section: Limit Of Quantitationmentioning

confidence: 99%

Review on method development and validation for different pharmaceutical dosage form

Vaishnawi R. Bhagwat,

Chetan M. Jain,

Nitin I. Kochar

et al. 2024

GSC Biol. Pharm. Sci.

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“…The LOQ was evaluated as the concentration that produced a peak with a signal-to-noise ratio of about 10. Specificity Chromatographic profiles : Solutions of albuterol formulation containing about 75g/mL were individually prepared and chromatographed [17]. Retention times and relative retention times were determined to evaluate the potential co-elution or interference to the determination of albuterol and/or the related substances.…”

Section: Limit Of Detection (Lod) and Limit Of Quantitation (Loq)mentioning

confidence: 99%

“…The stability of albuterol in prepared standard and sample solutions was evaluated under refrigerated condition. The assay values obtained at the end of the storage period were compared to the initial concentrations to evaluate the stability of solutions [17], [21], [22].…”

Section: Stability Of Standard and Sample Solutionsmentioning

confidence: 99%

Determination of Albuterol in Bulk and Dosage Form by HPLC Using Buffer-Ethanol System

Phanasekar¹,

Sharma²

2019

Journal of Harmonized Research in Applied Science

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Introduction: Asthma is a common condition due to chronic inflammation of the lower respiratory tract. Chronic lower airway inflammation is known to be more common in individuals that also have inflammatory disorders of the upper airway. The scientific understanding of asthma continues to improve and it is important for providers who treat upper or lower airway inflammation to be familiar with asthma's definition and pathophysiology. Asthma is a serious health and socioeconomic issue all over

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“…Under these circumstances, the pharmacopoeias may not provide standards and analytical techniques for these medications. Thus, the creation of more modern analytical techniques for such medications is required [4] . The development of analytical methods must follow the guidelines outlined in the International Conference on Harmonization (ICH) recommendations (Q2A and Q2B) and should be done in accordance with good manufacturing practise (GMP) and good laboratory practise (GLP) conditions .…”

Section: Introductionmentioning

confidence: 99%

“…The development of analytical methods must follow the guidelines outlined in the International Conference on Harmonization (ICH) recommendations (Q2A and Q2B) and should be done in accordance with good manufacturing practise (GMP) and good laboratory practise (GLP) conditions . [ 4,5] The ongoing process of method development moves on in lockstep with the development of the therapeutic product. The goal and purpose of the method should reflect the phase of drug development.…”

Section: Introductionmentioning

confidence: 99%

An Overview on Analytical Method Development & Validation of Drug: Amitriptyline HCL Using HPLC

Uppar¹,

Kamble²,

Bangar³

et al. 2023

Int. J. Res. Publ. Rev.

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The current article consists of a review and literature about the use of the drug Amitriptyline Hcl as an antipsychotic, antidepressant drug along with its analytical features.Here we have also discussed about the analytical methods that can be carried out such as spectroscopy, chromatography etc. Analytical techniques can be roughly divided between classical and instrumental techniques. Volumetry (titrimetric), gravimetry, gasometer, and other antiquated techniques are examples of the former classical techniques. Spectroscopic techniques (UV-Visible, FS, AS, IR, NMR, etc.). Electrophoreticmethods, Chromatographic methods (CC, TLC, HPTLC, HPLC, GC, etc.), and other instrumental methods. An overview of the analytical techniques used to analyse the drug amitriptyline is provided in this publication. This article will help to gain deep knowledge and previous work done Amitriptyline HCL.The article also provide information about the forced degradation studies and procedure to perform degradation studies according to ICH guidelines.

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Method Development and Validation of Analytical Procedures

Cited by 13 publications

References 13 publications

Review on method development and validation for different pharmaceutical dosage form

Review on method development and validation for different pharmaceutical dosage form

Determination of Albuterol in Bulk and Dosage Form by HPLC Using Buffer-Ethanol System

An Overview on Analytical Method Development & Validation of Drug: Amitriptyline HCL Using HPLC

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