High performance thin layer chromatography (HPTLC) method development and validation for determination of doxycycline hyclate in capsule and tablet formulations
نویسندگان
چکیده
Abstract According to World Health Organization (WHO) 10% of the medicines in Low and Middle Income Countries (LMICs) are poor quality posing a major public health threat. One way circumvent such problem is development deployment rapid, economical efficient analytical methods. Hence this research aims develop High-Performance Thin Layer Chromatography (HPTLC) method for determination doxycycline hyclate. A rapid simple HPTLC with densitometry detection at 360 nm determine hyclate capsules tablet formulations was developed validated. performed on glass plates coated C18 reverse phase silica gel 60 F 254 pretreated 0.27 M ethylenediaminetetraaceticacid (EDTA) solution. The mobile dichloromethane: methanol: acetonitrile: 1% aqueous ammonia ratio 10:22:53:15 (v/v). linearity range lies between 200 1,000 ng/spot correlation coefficient 0.997. R f value 0.5 ± 0.02%. Recoveries were 94.50–100.5%. Limit limit quantitation values 40 160 respectively. validated as per ICH guidelines. Thus, it found be accurate, precise, specific robust. In forced degradation study, degrade acidic alkaline media, through oxidative stress. drug relatively stable heat photo degradation. successfully applied routine quantitative analysis dosage forms containing offered comparable results (as confirmed by F-test) that HPLC pharmacopoeial (BP) method.
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ژورنال
عنوان ژورنال: Acta Chromatographica
سال: 2022
ISSN: ['2083-5736', '1233-2356']
DOI: https://doi.org/10.1556/1326.2021.00926