Validated High Performance Thin Layer Chromatographic Determination and Content Uniformity Test for Rosiglitazone in Tablets

Abstract

A simple, rapid, precise and economical high performance thin layer chromatographic method has been developed and validated for determination of rosiglitazone in its tablet dosage form using caffeine as an internal standard. It was performed on silica gel 60 GF254 thin layer chromatographic plates as a stationary phase using mobile phase methanol:toluene:chloroform:triethylamine (1:8:0.5:0.5 v/v/v/v) and the detection was carried out in the absorbance mode at 264 nm showing Rf value 0.31 for rosiglitazone and 0.52 for caffeine. The linear regression data curve shows good linear relationship in the concentration range 1.0-7.0 µg/µl. The content uniformity test was carried out as per USP specification of the content uniformity test of 85-115%. The percent drug estimated of rosiglitazone from two different marketed formulations were found to be in the range 99.83-100.21. The recovery of drugs was carried out by standard addition method were found to be 100.21±1.06 and 100.04±0.30 by height and area respectively. The method was validated with the determination of accuracy, precision, specificity, linearity detector response and ruggedness. The proposed method provides a faster and cost effective quality control tool for routine analysis of content uniformity test for rosiglitazone in tablet formulation.

Evaluation of the Quality of Different Brands of Ascorbic Acid in Freetown, Sierra Leone

“…This study evaluates the different brands of vitamin C (ascorbic acid) in Freetown using the following methods: thin layer chromatography test, uniformity of dosage unit, assay to determine the content of active pharmaceutical ingredients in the pharmaceutical tablet, colourimetric method, friability, and disintegration test [8].…”

“…The sample profile in table 1 describes the different brands of Vitamin C based on packaging, manufacturing country, storage condition, and the strength of ascorbic acid used. The uniformity of the dosage unit [8] for determining the consistency in the amount of ascorbic acid for each brand of vitamin C. Sample 2 was outside the required limit for the first assessment but was within the accepted limit for the second assessment. Therefore, all the samples in this study met the deviation and acceptance values as per the British Pharmacopoeia 2018.…”

Method Validation Approaches for Pharmaceutical Assessments – Highlights with High Performance Thin Layer Chromatographic (HPTLC) Techniques

“…The performance efficiency of this method can benefit from the HPTLC multi-channel capabilities. HPTLC has been successful applied in content uniformity of atorvastatin calcium tablets [47], diazepam tablets [48], diosgenin and levodopa [49], nicorandil tablets [50] and rosiglitazone in tablets [51]. All of these HPTLC method examples provide a faster, more cost efficient approach to quantitative testing for routine analysis.…”

Pharmaceutical Analysis and Diabetes Mellitus - A Review

“…This method used for the high degree of separation and purification of organic and inorganic samples with low cost. It also used for determination of impurities [7,11], for example, metformin [12][13][14], pioglitazone hydrochloride [15], glibenclamide, glimepiride [15,16], dasatinib [17], chlorpropamide [18], rosiglitazone [19], and nateglinide [14].…”

“…An NMR spectrum is produced due to the excitation of spin state of molecules in the presence of radio frequency rays. NMR spectroscopy is divided into various types such as H 1 , C 13 , F 19 , and P 31 . This method is used for qualitative analysis, to identify the structure of the drug molecules present in pharmaceuticals and biological samples.…”