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A validated new RP-HPLC method for simultaneous determination of amoxicillin, ampicillin and cloxacillin in pharmaceutical formulations

Gebretsadik Hailekiros, Kahsay Getu, Eticha Tadele, Gebretsadikan Tesfamichael

Acta Chromatographica

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2023

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Vol. 35, no. 2

193--203

EN

As per the World Health Organization, 10% of medicines in low- and middle-income nations are of poor quality and pose a huge public health risk. The development and implementation of cost-effective, efficient and quick analytical methods to control the quality of these medicines is one of the immediate strategies to avoid such a situation. Hence, the main goal of this study was to develop and validate a simple, specific and precise new RP–HPLC method for simultaneous analysis of amoxicillin, ampicillin and cloxacillin in pharmaceutical formulations. The chromatographic analysis was achieved using Shodex C18 (250 × 4.6 mm, 5 μm) column with UV detection at 225 nm. The mobile phase was a gradient mixture of 30 mM phosphate buffer, pH 4.0 (mobile phase A) and acetonitrile (mobile phase B). Efficient separation of the three drugs was obtained using the final optimized chromatographic conditions. The developed method was validated for its specificity, linearity, precision, accuracy and robustness as per the ICH guidelines. The validation results showed that the method was specific, linear, precise, accurate and robust for the simultaneous determination of the three drugs. The developed method was applied to determine the content of the three drugs in pharmaceutical formulations. The assay results of the preparations showed that their drug content was within the pharmacopeial limit stipulated for each drug product. It can be concluded that the proposed method is suitable for simultaneous determination of amoxicillin, ampicillin and cloxacillin in pharmaceutical formulations in industries and regulatory laboratories.

2

Development and validation of stability-indicating RP-HPLC method for the simultaneous determination of tizanidine HCL and meloxicam in rabbit's plasma

Zaman Muhammad, Hanif Muhammad, Khan Najm Ul Hassan, Mahmood Asif, Qaisar Muhammad Naeem, Ali Huma

Acta Chromatographica

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2019

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Vol. 31, no. 3

173--178

EN

High-performance liquid chromatography (HPLC) is a widely used technique for the simultaneous detection and quantification of different drugs. The purpose of the current study was to develop a simple and cost-effective reversed-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of tizanidine (TZN) HCl and meloxicam (MLX) in rabbit's plasma. Assay of TZN and MLX was performed after extraction of drug from plasma by liquid–liquid extraction technique using methanol and diethyl ether as protein precipitants. Isocratic elution was performed in a Kromasil® C18 column (dimension, 250 × 4.60 mm; particle size, 5 μm) with mobile phase consisting of methanol–water (8:2). Orthophosphoric acid was used to adjust the pH of the mobile phase 3.0, and detection was done at 228 nm. Flow rate was 0.8 mL/min with ambient temperature and average operating pressure of 1400 psig. Retention time of TZN was 2.612 min and that of MLX was 6.960 min with a resolution of 3.18. Both drugs showed satisfactory linearity in the range of 10 to 50 ng/mL with correlation coefficients (R2) of 0.9989 and 0.9972 for TZN and MLX, respectively. The developed method was validated successfully for linearity, system suitability, intra-day and inter-day accuracy, and precision, robustness, and specificity following International Conference on Harmonization (ICH) guidelines. Conclusively, a precise, stable, reproducible, economical, and suitable method for estimation of pharmacokinetic evaluation was developed and validated.

3

RP-HPLC–UV method for the quantification of propranolol in rat's serum and krebs buffer using one-step protein precipitation

Al Shaker H., Qinna Nidal A., Hroub H., Omari M. M. H., Adnan A.

Acta Chromatographica

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2018

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Vol. 30, no. 3

147--152

EN

Krebs buffer is considered one of the most used physiological buffers in biomedical research. In the current work, a rapid reversed-phase high-performance liquid chromatographic (RP-HPLC) method with ultraviolet (UV) detection at 214 nm was developed and validated according to European Medicines Evaluation Agency (EMEA) guidelines for the determination and quantification of propranolol in Sprague–Dawley rat's serum and in Krebs buffer. This method can be applied for both in vivo and in vitro studies with short run time of 7.0 min . Isocratic elution with a flow rate of 1.0 mL/min was employed. BDS Hypersil C-18 column (150 mm × 4.6 mm and 5 μm) was used to obtain satisfactory resolution. The mobile phase used contained a mixture of acetonitrile, methanol, and triethylammonium phosphate solution (15.0:32.5:52.5, v/v). Best separation between propranolol and the internal standard (I. S.) sildenafil was obtained at 4.2 and 5.5 min, respectively. Propranolol was linear over a concentration range of 50.00–3000 ng/mL with acceptable accuracy, and intra- and inter-day precision. Dilution integrity was assessed and was found to be within the acceptable range for both serum and Krebs buffer. Sample stability tests were studied at different storage conditions, and all the analytes were found to be stable. The mean percentage of recovery of propranolol was found to be 97.06% and 98.57% for serum and Krebs buffer, respective.

4

Development and validation of an HPLC-UV-MS-MS method for identification and quantification of polyphenols in Artemisia pallens L.

Niranjan A., Barthwal J., Lehri A., Singh D. P., Govindrajan R., Rawat A. K. S., Amla D. V.

Acta Chromatographica

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2009

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Vol. 21, no. 1

105-116

EN

Artemisia pallens L. (Compositae) is used in Indian traditional medicine to treat diabetes mellitus, jaundice, hysteria, body pain, and bacterial and fungal infections. A major cause of a variety of diseases is oxidative stress which is reduced by antioxidants such as polyphenols. These secondary metabolites are generally ubiquitous in plants and extensively used in the pharmaceutical, cosmetic, and food industries. In this study a simple and sensitive HPLC-UV-MS-MS-based method was developed for separation, identification, and quantification of polyphenols, for example gallic, protocatechuic, chlorogenic, caffeic, and ferulic acids, rutin, quercetin, and kaempferol. Amounts of polyphenols detected in 50% methanol-water extracts of the plant varied from 0.005% (kaempferol) to 0.24% (protocatechuic acid). Separation of the polyphenols was achieved on a reversed-phase C 18 with a mobile phase prepared from 1% aqueous with acetic acid and acetonitrile at a flow rate of 0.6 mL min -1 . The phenolic compounds were detected by UV absorption at 254 nm. The method was validated for linearity, accuracy, precision, LOD, LOQ, specificity, selectivity, and compound stability. Results from intra and inter-day validation (n = 6) showed the method was efficient and rapid. The optimized method was applied to extracts of A. pallens for identification and quantification of the polyphenols. The reference standards and their presence in A. pallens were confirmed by mass spectrometry.