High Performance Thin Layer Chromatographic (hptlc) Method Development And Validation For Determination Of Doxycycline Hyclate In Capsule Formulation

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The presence of Poor quality and counterfeited medicines in the market is a Public health concern. WHO estimated that 10 % of the medicines in the market are of poor quality. One major way to circumvent such problem is development and deployment of rapid, economical and efficient analytical methods to check the quality of drugs. Hence the aim of this research is to develop HPTLC method for the determination of Doxycycline hyclate pharmaceutical formulations.rnA rapid and simple high-performance thin layer chromatography (HPTLC) method with densitometry at 360 nm was developed and validated for determination of doxycycline hyclate in capsule formulation. Chromatography was performed on glass plates coated with C18 Reverse phase silica gel 60 F 254 and pretreated with 0.27 M EDTA solution; the mobile phase was dichloromethane: methanol: acetonitrile: 1% aqueous ammonia in the ratio of 10:22:53:15 (v/v). The linearity range lies between 200 and 1000 ng/spot with correlation coefficient of 0.997. The Rf value is 0.5 ± 0.02 %. Recoveries were in the range of 94.50 % – 100.5 %. Limit of detection and imit of quantitation values for doxycycline hyclate were 40 ng/spot and 160 ng/spot respectively. The developed method was validated as per ICH guidelines. In forced degradation study doxycycline was found to degrade in acidic, alkaline, and oxidative stress conditions and the drug was found to be relatively stable in heat and photo degradation (5 hr durations), the maximum degradation occurred under alkaline stress condition. The result in forced degradation study shows the specificity of the developed method. The proposed method was successfully applied for the routine quantitative analysis of dosage forms containing doxycycline hyclate. Five brands of tablets and capsules tested were in compliance with the USP requirements with respect to assay. The Developed method offered comparable results (as confirmed by F-test) with that of the HPLC pharmacopoeial analysis method. The method also offered efficiencies in terms of time and cost.

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High Performance Thin Layer Chromatographic (hptlc) Method Development And Validation For Determination Of Doxycycline Hyclate In Capsule Formulation

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