SASI GOUD - Academia.edu (original) (raw)
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Homi Bhabha National Institute (HBNI, BARC, MUMBAI)
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HAL (Le Centre pour la Communication Scientifique Directe), 2015
A sensitive, specific, precise and linear reverse phase HPLC method was developed for the analysi... more A sensitive, specific, precise and linear reverse phase HPLC method was developed for the analysis of related substances in Tapentadol in bulk and pharmaceutical dosage form. The known related substances are methoxy impurity [(2R, 3R)-3-(3-methoxyphenyl)-N,N,2-tri methyl pentanamine] and alcohol impurity [(2S)-1dimethylamino)-3-(3-methoxyphenyl)-2-methylpentan-3-ol hydrochloride]. The method was carried out on a Zodiac C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of phosphate buffer pH 7.0, acetonitrile and methanol in a gradient elution at a flow rate of 1.0ml/min at wavelength of 220 nm. The retention time of tapentadol was found to be 14±0.1 min, methoxy impurity was found to be 39.75±0.1 min and alcohol impurity was found to be 30.9±0.1min. The method can be used for the detection and quantitative estimation of known and unknown impurities in drug and pharmaceutical dosage form.
Three known impurities in Bendamustine Hydrochloride bulk drug were detected by a simple, sensiti... more Three known impurities in Bendamustine Hydrochloride bulk drug were detected by a simple, sensitive and accurate gradient reverse phase high performance liquid chromatography (HPLC). These impurities were isolated from crude sample of Bendamustine Hydrochloride using reverse phase HPLC. The IUPAC names of impurities were Impurity-A is 4-6-[2-chloro ethyl)-2-hydroxy ethyl amino)3 methyl-benzimidazolyl-2)-butyric acid (HP-1),Impurity- B is 4-(-5-[(4-5-(bis(2-hydroxyethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoic acid and Impurity - C Isopropyl 4-(5-(bis(2-chloroethyl)amino-1-methyl-1-H-benzol[d]imidazol-2yl)butanoate. The effective separation was achieved on a Zorbax SB-C18; (4.6 mm x 25 cm) 5μm using a gradient mode by the Mobile phase A : 0.1% Trifluroacetic acid in Water: Acetonitrile (90:10) and mobile phase B : 0.1% Trifluroacetic acid in Water: Acetonitrile (50:50). The flow rate of the mobile phase was 1.0 mL/min and the total elution time, including the column equilibr...
HAL (Le Centre pour la Communication Scientifique Directe), 2015
A sensitive, specific, precise and linear reverse phase HPLC method was developed for the analysi... more A sensitive, specific, precise and linear reverse phase HPLC method was developed for the analysis of related substances in Tapentadol in bulk and pharmaceutical dosage form. The known related substances are methoxy impurity [(2R, 3R)-3-(3-methoxyphenyl)-N,N,2-tri methyl pentanamine] and alcohol impurity [(2S)-1dimethylamino)-3-(3-methoxyphenyl)-2-methylpentan-3-ol hydrochloride]. The method was carried out on a Zodiac C18 column (250 mm x 4.6 mm; 5μ) using a mobile phase mixture of phosphate buffer pH 7.0, acetonitrile and methanol in a gradient elution at a flow rate of 1.0ml/min at wavelength of 220 nm. The retention time of tapentadol was found to be 14±0.1 min, methoxy impurity was found to be 39.75±0.1 min and alcohol impurity was found to be 30.9±0.1min. The method can be used for the detection and quantitative estimation of known and unknown impurities in drug and pharmaceutical dosage form.
Three known impurities in Bendamustine Hydrochloride bulk drug were detected by a simple, sensiti... more Three known impurities in Bendamustine Hydrochloride bulk drug were detected by a simple, sensitive and accurate gradient reverse phase high performance liquid chromatography (HPLC). These impurities were isolated from crude sample of Bendamustine Hydrochloride using reverse phase HPLC. The IUPAC names of impurities were Impurity-A is 4-6-[2-chloro ethyl)-2-hydroxy ethyl amino)3 methyl-benzimidazolyl-2)-butyric acid (HP-1),Impurity- B is 4-(-5-[(4-5-(bis(2-hydroxyethyl)amino)-1-methyl-1H-benzo[d]imidazol-2-yl)butanoic acid and Impurity - C Isopropyl 4-(5-(bis(2-chloroethyl)amino-1-methyl-1-H-benzol[d]imidazol-2yl)butanoate. The effective separation was achieved on a Zorbax SB-C18; (4.6 mm x 25 cm) 5μm using a gradient mode by the Mobile phase A : 0.1% Trifluroacetic acid in Water: Acetonitrile (90:10) and mobile phase B : 0.1% Trifluroacetic acid in Water: Acetonitrile (50:50). The flow rate of the mobile phase was 1.0 mL/min and the total elution time, including the column equilibr...