Estimation of four drugs: Ambroxol hydrochloride, Levocetirizine hydrochloride, Phenylephrine hydrochloride and Paracetamol by RP-HPLC in tablet dosage form

Devangi Patel, A. Vyas, M. Noolvi, A. Patel, Nilesh Patel
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引用次数: 3

Abstract

A simple, specific, precise, accurate and economic isocratic RP-HPLC method was developed for the simultaneous determination of Ambroxol hydrochloride, Levocetirizine hydrochloride, Phenylephrine hydrochloride and Paracetamol in bulk and tablet dosage form. A reverse phase Nucleosil C18 column (250 mm x 4.6 mm x 5 µm) with mobile phase consisting of Methanol: Sodium Phosphate dibasic anhydrous Buffer (65:35 V/V) having (pH of buffer 7.0 ± 0.02 adjusted with ortho phosphoric acid) was used. The flow rate was 1.0 mL/min and the effluents were monitored at 230 nm. The retention times of Paracetamol, Levocetirizine hydrochloride, Phenylephrine hydrochloride and Ambroxol hydrochloride were found to be 3.117, 4.925, 6.217 and 12.308 min. respectively. The method was validated in terms of linearity, range, specificity, accuracy, precision and robustness. The proposed method was successfully applied for the estimation of paracetamol, levocetirizine hydrochloride, phenylephrine hydrochloride and ambroxol hydrochloride in combined tablet dosage form. Keywords: Paracetamol (PCM), Levocetirizine hydrochloride (LEVO), Phenylephrine hydrochloride (PHEN), Ambroxol hydrochloride (AMB), Isocratic; RP-HPLC.
盐酸氨溴索、盐酸左西替利嗪、盐酸苯肾上腺素、扑热息痛4种药物片剂剂型的RP-HPLC评价
建立了同时测定盐酸氨溴索、盐酸左西替利嗪、盐酸苯肾上腺素和扑热息痛原料药和片剂含量的简便、特异、精确、准确、经济的等密度反相高效液相色谱法。采用反相Nucleosil C18色谱柱(250 mm × 4.6 mm × 5µm),流动相为甲醇:磷酸二钠无水缓冲液(65:35 V/V),缓冲液pH为7.0±0.02,用邻位磷酸调节。流速为1.0 mL/min,在230 nm处监测流出物。对乙酰氨基酚、盐酸左西替利嗪、盐酸苯肾上腺素和盐酸氨溴索的滞留时间分别为3.117、4.925、6.217和12.308 min。从线性、范围、特异性、准确度、精密度和鲁棒性等方面验证了该方法的有效性。该方法成功地应用于对乙酰氨基酚、盐酸左西替利嗪、盐酸苯肾上腺素和盐酸氨溴索联合片剂的含量测定。关键词:扑热息痛(PCM),盐酸左西替利嗪(LEVO),盐酸苯肾上腺素(PHEN),盐酸氨溴索(AMB),等度;产物。
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