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THE PHARMA REVIEW (SEPTEMBER - OCTOBER 2015)

Simultaneous Determination of Ranitidine Hydrochloride and Ondansetron Hydrochloride and their Degradation Products by HPTLC

Anup Barsagade & Rajendra Kakde

Introduction: The objective of current study was to develop a validated, specific stability indicating normal-phase high performance thin layer chromatographic method for simultaneous estimation of ranitidine hydrochloride and ondansetron hydrochloride in their combined dosage form. The forced degradation studies were performed on pure ranitidine hydrochloride and ondansetron hydrochloride and also on their combined dosage form using acid, base, neutral, oxidation, thermal and photo stress to show the stability indicating capability of the developed method. Significant degradation products of ranitidine hydrochloride were observed in acidic, basic, neutral, oxidation and photo stress. No degradation products were obtained after thermal stress condition. The chromatographic method was optimized using samples generated in forced degradation studies. Good separation between the peaks corresponding to the active pharmaceutical ingredients, ranitidine hydrochloride and ondansetron hydrochloride and degradation product from the analyte were achieved on silica gel 60F254 TLC plate chloroform: ethyl acetate: methanol: ammonia 4.5:2.5:2.0:0.3 (v/v) as mobile phase. Densitometric quantification was performed at 272 nm by reflectance scanning. The RF value of ranitidine hydrochloride and ondansetron hydrochloride were 0.48 0.03 and 0.77 0.03 respectively. Validation of the developed method was conducted as per ICH requirements. Response were a linear function of concentration of ranitidine hydrochloride over the range 12006000 ng/band by peak area with correlation coefficient 0.99778 and ondansetron hydrochloride over the range 32160 ng/band by peak area with correlation coefficient 0.99942. The limit of detection of ranitidine hydrochloride was 3.48 ng/band for peak area and the limit of detection of ondansetron hydrochloride was 0.64 ng/band for peak area. Results from analysis of a commercial tablet formulation were 100.17 0.4241 % and 100.12 0.8267 % by peak area for ranitidine hydrochloride and ondansetron hydrochloride respectively. Recoveries were 100.24 0.2493 % and 99.41 0.8125 % by peak area for ranitidine hydrochloride and ondansetron hydrochloride respectively. The developed HPTLC method was found to suitable to check the quality of ranitidine hydrochloride and ondansetron hydrochloride in combined dosage form. 

 

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