Development of a Validated Stability Indicating Method for Quantification of Amoxicillin, Clarithromycin and Lansoprazole in Bulk and Pharmaceutical Dosage form by RP-HPLC

Sushma, Patil; Pawar, A. K. M.; Divya, M.

doi:10.9734/jpri/2021/v33i45b32798

Cited by 1 publication

(2 citation statements)

References 20 publications

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“…The previously published methods [ 52 – 54 ] could not be used for content uniformity measurement for this encapsulated drug in their Tri-Pak dosage forms.…”

Section: Discussionmentioning

confidence: 99%

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Validated chromatographic approach for determination of two ternary mixtures in newly approved formulations for helicobacter pylori eradication: assessment of greenness profile and content uniformity

Salem,

Elsabour,

El-Masry

2024

BMC Chemistry

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A new, sensitive, and rapid isocratic reversed phase chromatographic method (RP-HPLC–UV) was developed for simultaneous separation of two newly co-formulated antiulcer mixtures; Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)], and Amoxicillin, Lansoprazole and Clarithromycin [Mixture (II)]. Analytical separation was performed using a Promosil C18 column and ultraviolet detection at 210 nm. The separation was achieved within only 8 min. For both mixtures, an aqueous solution, composed of (Acetonitrile: Methanol: 0. 2 M phosphoric acid) within ratio of (30: 30: 40) adjusted to final pH 3.0, was the mobile phase. This method was validated as per the International Conference on Harmonization guidelines. The linearity ranges of these proposed method of the (Mixture (I)) were 25.0–400.0 µg/mL Amoxicillin, 0.5–8.0 µg/mL Vonoprazan, and 12.5–200.0 µg/mL Clarithromycin. And the linearity ranges of the (Mixture (II)) were 10.0–300.0 µg/mL Amoxicillin, 0.3–9.0 µg/mL Lansoprazole and 5.0–150.0 µg/mL Clarithromycin. This method was firstly applied for effective separation of Amoxicillin, Vonoprazan and Clarithromycin [Mixture (I)]. It fulfilled good repeatability, sensitivity, and accuracy (R.S.D. < 2.0%). The mean recoveries of the analytes in their Tri-Pak formulations were acceptable. The greenness of the developed chromatographic methods was assessed using an Eco-scale method and it was applied for content uniformity testing as per the United States Pharmacopoeia (USP) and the acceptance value of Amoxicillin, in Mixture (I) was 2.88, the acceptance values for Amoxicillin, Lansoprazole in Mixture (II) were 2.592, 2.424, respectively.

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“…The previously published methods [ 52 – 54 ] could not be used for content uniformity measurement for this encapsulated drug in their Tri-Pak dosage forms.…”

Section: Discussionmentioning

confidence: 99%

“…Only two reported HPLC methods were published for the determination of AMOX, LAN, and CLA (Mixture (II)), both methods are time consuming and with sophisticated condition for separation [ 53 , 54 ].…”

Section: Introductionmentioning

confidence: 99%