ICH guidance in practice: Validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products

Kumar, Vijay; Bhutani, Hemant; Singh, Saranjit

doi:10.1016/j.jpba.2006.07.051

Cited by 46 publications

(30 citation statements)

References 18 publications

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“…The drug concentrations were determined using a stability-indicating HPLC assay method based on several references [10,11]. The HPLC system [10,[12][13][14] consisted of an isocratic solvent delivery pump (Model 515, Waters Scientific Co. USA) which pumped a mixture (v/v, 60/40, pH 3.0) of acetonitrile (ACN, Sigma Co. USA) in 0.05M potassium phosphate (Sigma Co. USA) through a Capsell Pak C18 UG120 (4.6 × 250 mm, 5 µm) column at 1.0 mL/min. The ratio of ACN to 0.05 M potassium phosphate (60/40) was held constant during the chromatographic run.…”

Section: Methodsmentioning

confidence: 99%

“…The standard plot was constructed for Ampicillin in the range of 0 -3.33 mg/mL. The experiment was repeated five times on the same day and additionally on four consecutive days to determine inter-and intra-day precisions [12]. Assays of control solutions from Ampicillin sodium solutions (3mg/mL) were undertaken to calculate the intra-day and inter-day variations using external standard method.…”

Section: Methodsmentioning

confidence: 99%

“…Periodically, samples were evaluated for appearances, visible particles, pH and chromatographic analysis. We analyzed the concentration of Ampicillin sodium in two solutions at each day during 7 days after the preparation of solutions by HPLC-UV method [10,12,13]. On each day, 1.0 mL of samples of Ampicillin sodium with a nominal concentration were drawn from Accufuser ® infusion device for chromatographic analysis and 2.0 µL were directly injected into HPLC-UV system.…”

Section: Methodsmentioning

confidence: 99%

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Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method

Kang¹,

Kang²

2012

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The stabilities of two kinds of solutions (30 mg/mL) of Ampicillin sodium in 0.9% NaCl in water (NS, normal saline) and in sterile water (SW) in the intravenous elastomeric infusion device (Accufuser ® ) were evaluated based on recommended solutions and storage periods. The injectable NS-and SW-Ampicillin solutions in the Accufuser ® device were stored and evaluated at controlled temperature (room temperature, 25˚C ± 2˚C and cold temperature, 4˚C ± 2˚C) during 7 days. Effects of the periods of storage (from 0 to 7 days) and the temperatures of storage (RT and CT) on the physicochemical appearances and concentrations of active compounds were determined. The visual clarity, pH, and concentrations of Ampicillin were determined by stability-indicating high-performance liquid chromatography (HPLC)-ultraviolet (UV) detection. The results showed that the amount of Ampicillin in studied solutions gradually decreased with time. The Ampicillin in NS, which was stored in CT, was relatively stable, retaining 94% of its original amount up to 7 days. The solution that showed least stability was Ampicillin in SW, which was stored in RT, retaining 80% of its original amount. Generally, solutions that were stored in CT were more stable than the solutions that were stored in RT. No significant changes in physical appearance or color of the solutions were observed during the study. Particles were not detected in any solution samples. In summary, two kinds of solutions of Ampicillin sodium, in NS and SW, showed different chemical stabilities with time in intravenous infusion device without any significant physical changes and retained about 94% vs 89% and 83% vs 80% of initial concentrations after 7 days in CT and RT, respectively. We suggest that 30 mg/mL of Ampicillin sodium in NS solution in an Accufuser ® infusion device which is stored in CT can be applicable for 7 days in clinical situations.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method

Kang¹,

Kang²

2012

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“…Ampicillin (AMP) and CLO are used against both Gram-positive and Gramnegative organisms, as well as those caused by penicilli- nase-producing staphylococci [9,10]. Other penicillins include dicloxacillin (DICLO) and oxacillin (OXA), which belong to the penicillinase-resistant penicillins.…”

Section: Introductionmentioning

confidence: 99%

“…During the last few decades, different methods have been proposed including CE and flow injection analysis [11,12], but most of them involve HPLC for the quantitative determination of penicillins [1, 6 -10, 13]. In the majority of papers, HPLC methods utilize UV detection at low wavelengths (f 230 nm) [9,10], although fluorimetric [8] and mass spectrometric detection [7] have also been reported. Sample preparation methods involve deproteinization and extraction techniques, such as LLE or for the most part SPE [1,5,6,13].…”

Section: Introductionmentioning

confidence: 99%

Development and validation of an HPLC method for the determination of seven penicillin antibiotics in veterinary drugs and bovine blood plasma

Samanidou¹,

Giannakis

Papadaki

2009

J of Separation Science

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Development and validation of an HPLC method for the determination of seven penicillin antibiotics in veterinary drugs and bovine blood plasma Herein a quantitative method for the determination of seven penicillins in bovine plasma and veterinary drugs has been developed. Amoxicillin (AMO), ampicillin (AMP), penicillin G (PENG), penicillin V (PENV), oxacillin (OXA), cloxacillin (CLO) and dicloxacillin (DICLO) were separated on a Perfectsil ODS-2 (25064 mm, 5 lm) column, using gradient elution, with a mobile phase of 0.1% v/v TFA and ACN -methanol (90:10 v/v). PDA detection was used at 240 nm. Penicillins were isolated from bovine plasma by SPE on Lichrolut RP-18 cartridges with mean recoveries from 85.7 to 113.5%. Colchicine (3 ng/lL) was used as an internal standard. The developed method was validated in terms of selectivity, linearity, accuracy, precision, stability and sensitivity. Repeatability (n = 5) and between-day precision (n = 5) revealed RSD a 12%. The detection limits in the bovine plasma were estimated as 18 ng for AMO and AMP, 25 for PENG, PENV and OXA, 3 ng for CLO and 12 ng for DICLO. Spiked plasma samples were stable for 1 wk, except for AMP and CLO, which were stable for 3 wk and OXA for 4 wk. AMO, PENG and PENV were stable for two freeze -thaw cycles, OXA, CLO and DICLO for four, while AMP only for one.

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High Performance Liquid Chromatography (HPLC) in the Pharmaceutical Analysis

Levin¹

2010

Pharmaceutical Sciences Encyclopedia

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High Performance Liquid Chromatograhy (HPLC) is the most important analytical technique used during the various stages of drug development and manufacturing. The key to a proper HPLC system operation is the knowledge of the principles of chromatographic process as well as the understanding of the reasons behind the choice of components of the chromatographic system. This article focuses on HPLC theory, its role in drug analysis, and its techniques.

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ICH guidance in practice: Validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products

Cited by 46 publications

References 18 publications

Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method

Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method

Development and validation of an HPLC method for the determination of seven penicillin antibiotics in veterinary drugs and bovine blood plasma

High Performance Liquid Chromatography (HPLC) in the Pharmaceutical Analysis

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ICH guidance in practice: Validated stability-indicating HPLC method for simultaneous determination of ampicillin and cloxacillin in combination drug products

Cited by 46 publications

References 18 publications

Stability Test of Ampicillin Sodium Solutions in the Accufuser&#174; Elastomeric Infusion Device Using HPLC: UV Method

Stability Test of Ampicillin Sodium Solutions in the Accufuser&#174; Elastomeric Infusion Device Using HPLC: UV Method

Development and validation of an HPLC method for the determination of seven penicillin antibiotics in veterinary drugs and bovine blood plasma

High Performance Liquid Chromatography (HPLC) in the Pharmaceutical Analysis

Contact Info

Product

Resources

About

Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method

Stability Test of Ampicillin Sodium Solutions in the Accufuser® Elastomeric Infusion Device Using HPLC: UV Method