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A Validated LC Method for the Determination of Chiral Purity of (S)-2-azido3-methylbutanoic acid: A key Raw material of

A Validated LC Method for the Determination of Chiral Purity of (S)-2-azido3-methylbutanoic acid: A key Raw material of

A simple and accurate normal phase liquid chromatographic method was developed for the determination of chiral purity of (S)-2-azido-3-methylbutanoic acid, S-enantiomer used as key starting raw material in the manufacturing of valganciclovir hydrochloride bulk drug. Chromatographic separation between (S)-2-azido-3-methylbutanoic acid and its opposite enantiomer (R)-2-azido-3-methylbutanoic acid, R-enantiomer was achieved using a Chiralpak IA column using a mobile phase containing n-hexane, ethanol, isopropyl alcohol and tri-fluoro acetic acid (98:1.5:0.5:0.1 v/v/v/v). The resolution between the two enantiomers was found to be more than 2.0. The limit of detection (LOD) and limit of quantification (LOQ) of the Renantiomer was 0.15 and 0.5 µg mL-1, respectively, for 10 µL injection volume. The percentage recoveries of the R-enantiomer ranged from 96.5 to 105.3 in the samples of (S)-2-azido-3- methylbutanoic acid. The test solution and mobile phase was observed to be stable up to 24 h after the preparation. The developed method was validated as per International Conference on Harmonization guidelines in terms of LOD, LOQ, precision, linearity, accuracy, robustness and ruggedness.

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88 views • 7 slides
Method development and validation for simultaneous estimation of Paracetamol and Etoricoxib in pharmaceutical dosage for

Method development and validation for simultaneous estimation of Paracetamol and Etoricoxib in pharmaceutical dosage for

A RP-HPLC method was developed for simultaneous estimation of Paracetamol and Etoricoxib tablet formulation using Phenomenex Luna C18 column (250 mm × 4.6 mm id, 5 µm particle size) and a mobile phase of methanol : water (70:30 v/v), at flow rate 1.0 ml/min with UV detection at 235 nm. The retention time (tR) of Paracetamol and Etoricoxib found to be 3.07 and 5.72 min respectively. The proposed method was validated for system suitability, specificity, linearity, accuracy, precision, LOD, LOQ and robustness. All parameters were found to be within the acceptance limit. Linearity over the concentration range 5-30 µg/ml for both Paracetamol and Etoricoxib with regression coefficient (r2 ) 0.9998 and 0.9994 respectively. Limit of detection (LOD) found to be 0.10 µg/ml and 0.04 µg/ml whereas limit of quantitation (LOQ) found to be 0.33 µg/ml and 0.13 µg/ml for Paracetamol and Etoricoxib respectively. The accuracy of the proposed method was determined by recovery studies and found to be 99.74%- 101.25% and 99.08%-99.21% for Paracetamol and Etoricoxib respectively.

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266 views • 6 slides
A rapid RP-HPLC method for the estimation of famciclovir in tablet dosage forms

A rapid RP-HPLC method for the estimation of famciclovir in tablet dosage forms

A rapid and simple RP-HPLC chromatographic method has been developed for the estimation of famciclovir in API and tablet dosage form.

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82 views • 5 slides
ja2013136x2

ja2013136x2

Supplementary Fig. S1a. Two-dimensional thin-layer chromatogram stained with molybdatophosphoric acid reagent for polar lipids of strain H53 T . The chromatographic conditions were as follows. Silica Gel 60 thin-layer plates (10 by 10 cm) were spotted with 15 ?l of a whole-cell lipid extract.

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173 views • 2 slides

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