Development of a new visible Spectrophotometric analytical method for determination of Vildagliptin in bulk and Pharmaceutical dosage forms

: Inductively coupled plasma is a new technique employed for the determination of elemental impurities in pharmaceutical ingredients viz. raw materials, drug substance, and drug product dosage forms. New US FDA and EMA regulations came into effect from Jan 2018 as industry standard requirements for the determination of inorganic elemental impurities using ICP-OES/AES or ICP-MS analytical techniques. The method development was optimized for the determination of the listed elements as per USP <232> <233> elemental impurities-limits and procedures. It also demonstrates the validation of the method and verification/transfer of the method which also provides an insight into the presence of free elemental atomics of the gaseous form of the sample (drug substance, drug product or excipients), thus helping in determining the concentration of the element of interest. Also, the regulatory guidance is very general and does not explain the sample specifications for the individual element concentrations. Thus, this review emphasizes the routine instrumental maintenance, analytical method development challenges, trends in the performance of analytical method validation and verification/ transfer activities of the various pharmaceutical dosage forms outlined with acceptance criterion.

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Development and Validation of a New Analytical Method for the Determination of Related Components and Assay of Ranolazine in Bulk Drug and Pharmaceutical Dosage Forms by LC

Chromatographia ◽

10.1365/s10337-009-1145-5 ◽

2009 ◽

Vol 70 (1-2) ◽

pp. 333-338 ◽

Cited By ~ 3

Author(s):

A. Madhavi ◽

D. V. Subba Rao ◽

P. Srinivasu ◽

A. Naidu

Keyword(s):

Analytical Method ◽

Dosage Forms ◽

Pharmaceutical Dosage Forms ◽

Bulk Drug ◽

Development And Validation

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Development and Validation of a RP-HPLC Method for Simultaneous Determination of Levofloxacin and Moxifloxacin in Pharmaceutical Dosage Forms

Dhaka University Journal of Pharmaceutical Sciences ◽

10.3329/dujps.v12i2.17614 ◽

2014 ◽

Vol 12 (2) ◽

Author(s):

Farjahan Nur ◽

Asma Rahman ◽

Md. Zakir Sultan ◽

Md. Gias Uddin ◽

Mohammad A Rashid

Keyword(s):

Simultaneous Determination ◽

Dosage Forms ◽

Hplc Method ◽

Pharmaceutical Dosage Forms ◽

Rp Hplc ◽

Development And Validation

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Spectrophotometric Determination of Alendronate Sodium by using Sodium-1,2-Naphthoquinone-4-Sulphonate

International Journal of Pharmaceutical Sciences and Nanotechnology ◽

10.37285/ijpsn.2011.4.4.7 ◽

2012 ◽

Vol 4 (4) ◽

pp. 1563-1568

Author(s):

Sagar Suman Panda ◽

Ravi Kumar B V V ◽

D Patanaik

Keyword(s):

Spectrophotometric Method ◽

Absorption Maximum ◽

Dosage Form ◽

Dosage Forms ◽

Alendronate Sodium ◽

Colored Complex ◽

Pharmaceutical Dosage Forms ◽

Recovery Study ◽

Assay Conditions

A simple, precise and accurate spectrophotometric method was developed for analysis of the osteoporesis drug alendronate sodium (ALS). The method is based on reaction of the drug with sodium-1,2-naphthoquinone-4-sulphonate (NQS) in presence of alkali to form a brown colored complex giving absorption maximum at 525 nm. The drug obeyed Beer’s law in the range of 5-70 µg/ml with a correlation coefficient of 0.999. The LOD and LOQ values are 1.7 µg/ml and 5.0 µg/ml, respectively. The average recoveries for recovery study were found to be in the range of 99.37%-100.46%. The R.S.D. values for intraday and inter-day precision were found to be 0.48 and 0.62, respectively. The optimized assay conditions were applied successfully for determination of ALS in pharmaceutical dosage forms. No interference was observed from the excipients present in the dosage form. The method is statistically validated as per the ICH requirements.

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Electroanalytical Methods for Determination of Calcium Channel Blockers

Current Analytical Chemistry ◽

10.2174/1573411014666180426165750 ◽

2019 ◽

Vol 15 (3) ◽

pp. 207-218 ◽

Cited By ~ 1

Author(s):

Fatma Ağın

Keyword(s):

Calcium Channel ◽

Calcium Channel Blockers ◽

Channel Blocker ◽

Heart Diseases ◽

Dosage Forms ◽

Channel Blockers ◽

Electroanalytical Methods ◽

Pharmaceutical Dosage Forms ◽

Ischemic Heart Diseases

Background:Calcium Channel Blockers (CCBs) are widely used in the treatment of cardiovascular and ischemic heart diseases in recent years. They treat arrhythmias by reducing cardiac cycle contraction and also benefit ischemic heart diseases. Electroanalytical methods are very powerful analytical methods used in the pharmaceutical industry because of the determination of therapeutic agents and/or their metabolites in clinical samples at extremely low concentrations (10-50 ng/ml). The purpose of this review is to gather electroanalytical methods used for the determination of calcium channel blocker drugs in pharmaceutical dosage forms and biological media selected mainly from current articles.Methods:This review mainly includes recent determination studies of calcium channel blockers by electroanalytical methods from pharmaceutical dosage forms and biological samples. The studies of calcium channel blockers electroanalytical determination in the literature were reviewed and interpreted.Results:There are a lot of studies on amlodipine and nifedipine, but the number of studies on benidipine, cilnidipine, felodipine, isradipine, lercanidipine, lacidipine, levamlodipine, manidipine, nicardipine, nilvadipine, nimodipine, nisoldipine, nitrendipine, diltiazem, and verapamil are limited in the literature. In these studies, DPV and SWV are the most used methods. The other methods were used less for the determination of calcium channel blocker drugs.Conclusion:Electroanalytical methods especially voltammetric methods supply reproducible and reliable results for the analysis of the analyte. These methods are simple, more sensitive, rapid and inexpensive compared to the usually used spectroscopic and chromatographic methods.

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