Development and Validation of a Stability-Indicating RP-UPLC Method for Determination of Cloxacillin Sodium in Its Bulk Form and Formulation

Abstract

A simple, linear gradient, rapid, precise and stability-indicating RP-UPLC method was developed for the determination of Cloxacillin Sodium in its bulk form and formulation. Ultra performance liquid chromatography, a most promising advancement in a world of chromatography, reduces analysis time, increases reliability through higher resolution, sensitivity and selectivity as well as used as an economic method due to reducing solvent consumption. A chromatographic separation of a drug as well as its degradants was achieved using Waters acquity BEH, 2.1 × 100 mm, 1.7 μm C18 column with gradient of mobile phase A: phosphate buffer, pH 6.8 and mobile phase B: methanol:acetonitrile (75:25). The drug and degradants were monitored at a detection wavelength of 225 nm with a flow rate of 0.35 mL/min and an injection volume of 10 µL. The temperature of the column and auto sampler compartments was at 30°C and 25°C ± 1°C, respectively. The retention time of the drug was ∼6.9 min. The resolution of the drug and degradant peak was >1.5 in all cases. Force degradation of CLOX SOD was carried under alkaline, acidic, oxidative, thermal, photo degradation conditions and it was analyzed by the proposed method. The drug degrades under alkaline, acidic and oxidative conditions but was stable in temperature and light. A developed method was validated as per ICH guidelines using validation parameters such as precision, linearity and range, limit of quantification, specificity, assay and robustness.

Ampicillin Stability in a Portable Elastomeric Infusion Pump: A Step Forward in Outpatient Parenteral Antimicrobial Therapy

“…AMP was assayed with a previously validated method [ 23 ] using an ACQUITY UPLC H-Class System (Waters; Milfors, MA, USA) with ACQUITY PDA detector (Waters; Milfors, MA, USA). The column used was ACQUITY ® BEH C18 column (2.1 × 50 mm, 1.7 μm, Waters) at a temperature of 30 °C with a VanGuard 2.1 × 5 mm (Waters; Milfors, MA, USA) pre-column.…”

Development and validation of a single HPLC method for the determination of thirteen pharmaceuticals in bulk and tablet dosage form

“…( 1 (Metformin), 2 (Amoxicillin), 3 (Chloroquine), 4 (Theophylline), 5 (Trimethoprim), 6 (Caffeine), 7 (Norfloxacin), 8 (Ciprofloxacin), 9 (Acetyl salicylic acid), 10 (Doxycycline hyclates), 11 (Metronidazole), 12 (Albendazole), 13 (Cloxacillin))…”

“…Widely used antibiotics include amoxicillin (AMOX), which is used to combat bacterial infections [5], and ciprofloxacin (CIP) a synthetic fluoroquinolone derivative with broad-spectrum activity against many pathogenic gram-positive bacteria [6]. Cloxacillin (CLA) belongs to the semi-synthetic β-lactam antibiotics used against staphylococci that produce beta-lactamas [7], while doxycyclinehyclate (DOXH), a broad spectrum tetracycline antibiotic with a large range of antibacterial activities [8]. A member of the fluoroquinolones third-generation antibiotics, norfloxacine (NOR), is used for the treatment of diseases caused by Campylobacter, Escherichia coli, Shigella and Vibrio cholera and used to treat gonorrhea and urinary tract infection [9].…”

Study on the impurity profiles of cloxacillin and flucloxacillin based on liquid chromatography tandem ion trap/time‐of‐flight mass spectrometry

“…β ‐Lactam antibiotic polymers have long been recognized to trigger allergic manifestations 11–15 . Therefore, it is essential to characterize and control these impurities in cloxacillin and flucloxacillin, especially polymerized impurities.…”