Abstract

Objective. Three sensitive, selective, and precise spectrophotometric methods based on manipulation of ratio spectra, have been developed and validated for the determination of diclofenac sodium and pantoprazole sodium. Materials and Methods. The first method is based on ratio spectra peak to peak measurement using the amplitudes at 251 and 318 nm; the second method involves the first derivative of the ratio spectra (Δλ = 4 nm) using the peak amplitudes at 326.0 nm for diclofenac sodium and 337.0 nm for pantoprazole sodium. The third is the method of mean centering of ratio spectra using the values at 318.0 nm for both the analytes. Results. All the three methods were linear over the concentration range of 2.0–24.0 μg/mL for diclofenac sodium and 2.0–20.0 μg/mL for pantoprazole sodium. The methods were validated according to the ICH guidelines and accuracy, precision, repeatability, and robustness are found to be within the acceptable limit. The results of single factor ANOVA analysis indicated that there is no significant difference among the developed methods. Conclusions. The developed methods provided simple resolution of this binary combination from laboratory mixtures and pharmaceutical preparations and can be conveniently adopted for routine quality control analysis.

Highlights

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) are a class of drugs that provide analgesic, antipyretic, and antiinflammatory effects [1]

  • The threats of peptic ulcer on long-term use of DCL require concomitant treatment with proton pump inhibitors as they have been shown to be effective in preventing the development of gastric and duodenal ulcers in high-risk patients taking NSAIDs [4]

  • Molecular absorption spectroscopy has been extensively used for the determination of drugs in pharmaceutical preparations with a view to develop simple, rapid, and reliable analytical methods

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Summary

Introduction

Nonsteroidal anti-inflammatory drugs (NSAIDs) are a class of drugs that provide analgesic, antipyretic, and antiinflammatory effects [1]. Diclofenac (DCL, Figure 1(a)) is one of the most prescribed NSAIDs worldwide, used to reduce inflammation and as an analgesic to reduce pain in certain other conditions [2]. The primary mechanism responsible for anti-inflammatory, antipyretic, and analgesic action of DCL is thought to be inhibition of prostaglandin synthesis by inhibition of cyclooxygenase (COX) [3]. Inhibition of COX decreases prostaglandins in the epithelium of the stomach, making it more sensitive to corrosion by gastric acid. The threats of peptic ulcer on long-term use of DCL require concomitant treatment with proton pump inhibitors as they have been shown to be effective in preventing the development of gastric and duodenal ulcers in high-risk patients taking NSAIDs [4].

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