HPLC-DAD Stability Indicating Determination of Nitrofurazone and Lidocaine Hydrochloride in Their Combined Topical Dosage Form

Abstract

In this work, a simple, rapid, and selective high-performance liquid chromatography (HPLC) method with diode array detection was developed for the simultaneous determination of nitrofurazone (NZ) and lidocaine hydrochloride (LD). The chromatographic separation was achieved by using Zorbax Eclipse XDB-C(18) (4.6 x 150 mm, 5 mum p.s.) analytical column and a mobile phase composed of 0.025 M disodium hydrogen phosphate-methanol-triethylamine (70:30:0.1, v/v/v) (pH 4.0) at a flow rate of 1 mL/min. The detector was set at wavelengths 374 and 220 nm for NZ and LD, respectively, and quantification of the analytes was based on measuring their peak areas. The retention times for NZ and LD were approximately 4.5 and 5.7 min, respectively. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to system suitability, linearity, ranges, precision, accuracy, selectivity, robustness, and detection and quantification limits. The linear dynamic ranges were 0.5-25 and 2.5-100 mug/mL for NZ and LD, respectively, with correlation coefficients > 0.999. The stability-indicating aspects of the proposed method were demonstrated by the resolution of the two analytes from the related substance and potential impurity (2,6-dimethylaniline) as well as from forced-degradation products. The validated HPLC method was successfully extended to the analysis of the combined topical dosage form (soluble dressing) where no interfering peaks were encountered from the dosage form matrix or the inactive ingredients.

Formulation and optimisation of novel transfersomes for sustained release of local anaesthetic

“…Development of an HPLC method as an accurate method for the analysis of lidocaine free‐base was necessary because the UV spectrophotometer was the most reported way to quantify the free‐base, and all other reported HPLC methods were developed for the analysis of lidocaine HCl . Several methods suggested the use of ACN and PBS as mobile phase components for lidocaine analysis .…”

“…Several methods suggested the use of ACN and PBS as mobile phase components for lidocaine analysis . To achieve good peak resolution, the use of a mobile phase with a basic pH has been suggested, while others have proposed the use of MeOH instead of CAN . Therefore, method optimisation and validation were required in order to improve lidocaine free‐base analysis and investigation in formulations.…”

“…Development of an HPLC method as an accurate method for the analysis of lidocaine free-base was necessary because the UV spectrophotometer was the most reported way to quantify the free-base, and all other reported HPLC methods were developed for the analysis of lidocaine HCl. [23][24][25][26][27] Several methods suggested the use of ACN and PBS as mobile phase components for lidocaine analysis. [23][24][25][26] To achieve good peak resolution, the use of a mobile phase with a basic pH has been suggested, while others have proposed the use of MeOH instead of CAN.…”

Simultaneous determination of eleven alkaloids in Corydalis decumbens by HPLC with diode-array detection

“…Better separation efficiency and sensitivity were achieved with acetonitrile than methanol [21]. Using 0.2% acetic acid and triethylamine in the solvent system can reduce the ionization of alkaloids and give more symmetrical peaks and a better separation [31,32]. The proportion of each mobile phase gradient is closely related to the resolution since all studied alkaloids cannot be well separated by isocratic elution [31].…”

Validated Selective HPLC-DAD Method for the Simultaneous Determination of Diclofenac Sodium and Lidocaine Hydrochloride in Presence of Four of Their Related Substances and Potential Impurities

“…These reports suggested the use of HPLC with UV detection [34,35], HPLC with amperometric detection [36], thin-layer chromatography (TLC)-densitometry [37], and derivative spectrophotometry [37]. Recently, several HPLC-DAD methods have been published for the stabilityindicating assay of LD in presence of its related substance in several pharmaceutical combinations [38][39][40]. DC and LD have been coformulated in ampoules dosage form for the treatment of exacerbation of inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, osteoarthritis, and other painful conditions.…”