Simultaneous Determination of Dexpanthenol, Lidocaine Hydrochloride, Mepyramine Maleate and their Related Substances by a RP-HPLC Method in Topical Dosage Forms

Abstract

The pharmaceutical combination of dexpanthenol (DPA), lidocaine hydrochloride (LIH) and mepyramine maleate (MAM) is used for their anti-allergic, anti-inflammatory, anti-pruritic, anesthetic and antiseptic properties. The present study was aimed to develop and validate a new, first and rapid high performance liquid chromatographic method for simultaneous determination of DPA, LIH and MAM in the presence of their stress-induced degradation products in pharmaceutical gel/fluigel formulations. The chromatographic separation was performed on an Inertsil ODS-3 V, 250 × 4.6 mm (5 μm) column using a gradient mobile phase of an aqueous solution of ammonium acetate (0.01 M) and methanol mixture at gradient flow rates of 1.3 mL/min and 1.5 mL/min with detection at 230 nm. The retention times for DPA, LIH and MAM were ~3.28 min, 11.67 min and 12.99 min, respectively. The method was validated in accordance with International Conference on Harmonisation guidelines. Calibration curves were linear in the ranges of 9-54 μg/mL for MAM and LIH and 30-180 μg/mL for DPA with satisfactory correlation coefficients (R2 > 0.999). The mean % recoveries obtained were found to be 99.9% for MAM, 100.3% for LIH and 99.3% for DPA. Precision % RSD was <2. Robustness results were uniform, there were no marked changes, so method is highly validated. All drugs were subjected to stress conditions and degradation products were separated with acceptable peak tailing (T ≤ 2) and good resolution (Rs > 2). The validated method therefore can be adapted for quality control procedures of the drugs in pharmaceutical dosage forms and their stability studies.

A New and Sensitive HPLC-UV Method for Rapid and Simultaneous Quantification of Curcumin and D-Panthenol: Application to In Vitro Release Studies of Wound Dressings

“…CUR is present in yellowish solution due to long intense wavelength absorption in the visible region [ 14 ]; therefore, it was analysed at 425 nm. On the other hand, DPA is a colourless liquid and does not exhibit strong UV–visible absorption; therefore, it must be quantified by using a low UV wavelength [ 12 , 15 ]. Accordingly, we analysed DPA at 200 nm.…”

“…Some previous studies have reported HPLC methods to determine DPA or CUR independently. However, there are some previously published works describing the simultaneous determination of DPA and other compounds such as lidocaine, mepyramine or resorcinol in different formulations [ 12 , 20 ]. These methods presented higher LOD and LOQ values than the ones reported in this work.…”

“…For CUR, two different methods have been applied using reverse-phase (RP)-HPLC with UV detection at 425 nm, which obtained LOQ values of 2.73 μg/mL [ 9 ] and 0.5 μg/mL [ 10 ]. Additionally, RP-HPLC methods were also applied for DPA detection and quantification at 205 nm with LOQ values of 6.2 μg/mL [ 11 ] and 13.72 μg/mL [ 12 ].…”

An isocratic RP-HPLC-UV method for simultaneous quantification of tizanidine and lidocaine: application to in vitro release studies of a subcutaneous implant

“…21 Additionally, other validated methods exist for determining the drug in polymeric matrices, [26][27][28] plasma, 29,30 and in new topical dosage forms. 25,[31][32][33] Methods for the quan-tication of TZ, on the other hand, were described for analysing the drug alone, 34,35 concurrently with other drugs like muscle relaxants, 36 analgesics, [37][38][39] and anti-inammatories, [40][41][42][43][44][45][46][47][48] and from pharmaceutical formulations. 2,38,42,[44][45][46][47][48][49][50][51] Moreover, a method has been described for detecting TZ in skin deposition 52 and plasma.…”

Sophisticated Planar Chromatographic Method Estimation and Validation for Newer Combination of Lidocaine HCl and Diltiazem HCl For Anal Fissure

“…Extensive study of the literature [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21], it was discovered that many analytical techniques for LID estimation had been published, including ultraviolet, high performance liquid chromatography, RP-HPLC, HPLC-MS/MS, etc. Methods for analysing DIL had been documented, including Ultra violet, high performance liquid chromatography, high performance thin layer chromatography, etc.…”