Determination of isotretinoin in pharmaceutical formulations by reversed-phase HPLC

Abstract

The development of facile and rapid quantification of biologically active biomolecules such as isotretitoin in therapeutic drugs contained in many generic formu- lations is necessary for determining their efficiency and their quality to improve the human health care. Isotretritoin finds its applications in the maintenance of epithelial tissues. Different processes to date such as normal phase HPLC, or gas chromatrography am- ong others are able to separate and quantify isote- troin. However, the extraction is quite complex and in the case of HPLC, the analysis requires long retention times. In such context, an isocratic reversed- phase high-performance liquid chromatography (HP- LC) technique coupled with an UV-vis detector is described here for easy separation and quantification of 13-cis-retinoic (isotretinoin) from soft gelatin capsule formulations. The isotretinoin was extracted from three different commercial drug samples with tetrahydrofuran (THF) solvent by a procedure that can be completed in less than 10 minutes. Subsequent separation and quantification were accomplished in less than 5 minutes under isocratic reversed-phase conditions on a Lichrospher RP18 column and a mobile phase consisting of 0.01% TFA/acetonitrile (15/85, v/v) at a flow rate of 1.0 mL/min. Isotretoin was detected for the three samples via its UV-vis absorbance at 342 nm. The method was validated and the results showed good linearity, precision and accuracy for sensitive and selective quantitative determination of isotretinoin in the different pharmaceutical formulations. We found that the average isotretinoin content in two of the three commercial pro- ducts fell outside the 90-110% United States Pha- rmacopeia specifications. Consequently, the facile extraction and the precise method for the biomole- cule quantification open up tremendous possibilities in improving the quality control of drugs which can exist as different generic brands

Environmentally friendly stability-indicating HPLC method for the determination of isotretinoin in commercial products and solubility samples

“…In addition, the accuracy of one of the reported HPLC methods was inferior to the current HPLC method [ 31 ]. However, the accuracy and precision of most of the reported HPLC methods was similar to the current HPLC method [ 32 , 33 , 50 ]. The LOD and LOQ values of reported HPLC methods were also inferior to the current HPLC method and hence the current HPLC method was more sensitive than reported ones [ 33 , 50 ].…”

“…Numerous validation parameters of current method compared with reported HPLC methods are provided in Table 6 . The linearity of all reported HPLC methods was inferior to the current HPLC method [ [31] , [32] , [33] , 50 ]. In addition, the accuracy of one of the reported HPLC methods was inferior to the current HPLC method [ 31 ].…”

“…For the quantitative estimation of ITN as well as its metabolite in biological samples, a variety of liquid chromatographic techniques have been used, including high-performance liquid chromatography (HPLC) with detections ranging from UV detection [ [21] , [22] , [23] , [24] ], mass spectrometry [ [25] , [26] , [27] , [28] ] or tandem mass spectrometry [ 29 , 30 ]. Numerous HPLC methods with UV detection have also been reported to determine ITN in pharmaceutical dosage forms [ [31] , [32] , [33] ].…”

A review of HPLC technique covering its pharmaceutical, environmental, forensic, clinical and other applications

“…This method is not time-consuming and is easy to perform in any laboratory. 32 Development and application of a validated HPLC method for the analysis of dissolution samples of levothyroxine sodium drug products: Current USP methodology for levothyroxine (L-T4) is not adequate to resolve co-elutants from a variety of levothyroxine drug product formulations. So, a gradient HPLC method was developed for the analysis of dissolution samples of levothyroxine sodium tablets.…”

Spectrophotometric Micro Determination of Tretinoin, Isotretinoin using Iodine and Tazarotene micro determination via Reaction with Rose-Bengal Reagent

“…1. For determination of retinoids in dermatological formulations, there are few UV-Visible spectroscopic methods reported [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17], but there are several other methods have been reported for the determination like chromatography [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34]12]. However, most of these methods are complicated and not available at most laboratories.…”