title: Development and validation of simultaneous spectrophotometric and TLC-spectrodensitometric methods for determination of beclomethasone dipropionate and salbutamol in combined dosage form.
abstract: Spectrophotometric and TLC-spectrodensitometric methods were developed and validated for the simultaneous determination of beclomethasone dipropionate (BEC) and salbutamol (SAL). The spectrophotometric methods include dual wavelength, ratio difference, constant center coupled with a novel method namely, spectrum subtraction and mean centering with mean percentage recoveries and RSD 99.72±1.07 and 99.70±1.12, 100.25±1.12 and 99.89±1.12, 99.66±1.85 and 99.19±1.32, 100.74±1.26 and 101.06±0.90 for BEC and SAL respectively. The TLC-spectrodensitometric method was based on separation of both drugs on TLC aluminum plates of silica gel 60 F254, using benzene: methanol: triethylamine (10:1.5:0.5 v/v/v) as a mobile phase, followed by densitometric measurements of their bands at 230 nm. The mean percentage recoveries and RSD were 99.07±1.25 and 101.35±1.50 for BEC and SAL respectively. The proposed methods were validated according to ICH guidelines and were applied for the simultaneous analysis of the cited drugs in synthetic mixtures and pharmaceutical preparation. The methods were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of BEC and SAL in their pharmaceutical formulation with no need for prior separation. The results obtained were statistically compared to each other and to that of the reported HPLC method. The statistical comparison showed that there is no significant difference regarding both accuracy and precision.
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts, Egypt. Electronic address: samiraboelnoor@gmail.com.
authors.forename: Ahmed
authors.initials: A
authors.lastname: Samir
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Egypt.
authors.forename: Hayam M
authors.initials: HM
authors.lastname: Lotfy
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts, Egypt.
authors.forename: Hesham
authors.initials: H
authors.lastname: Salem
authors.affiliation: Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Egypt.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Abdelkawy
mesh_terms: D000420:Albuterol / Q000032:analysis*; D001507:Beclomethasone / Q000032:analysis*; D002855:Chromatography, Thin Layer / Q000379:methods; D013053:Spectrophotometry / Q000379:methods
chemical_list: D001507:Beclomethasone; D000420:Albuterol
keywords: Beclomethasone dipropionate; Constant center; Mean centering; Ratio difference; Salbutamol; Spectrum subtraction