Palestinian Medical and Pharmaceutical Journal (Pal. Med. Pharm. J.)

Journal metrics

Journal metrics

Metrics and turnaround details

First decision 7 Days
Submission to acceptance 45 Days
Acceptance to publication 14 Days
Acceptance rate 8%

Scopus

Scopus profile

This journal is indexed in Scopus. Use these metrics for a quick publishing snapshot, then open the Scopus page for the authoritative profile.

Scopus
Palestinian Medical and Pharmaceutical Journal (Pal. Med. Pharm. J.) Indexed in Scopus since 2022
CiteScore 1.0
Indexed since 2022

SCImago

SCImago Journal Rank preview

Use SCImago when you want a quick visual view of the journal ranking profile and external discoverability signals.

Palestinian Medical and Pharmaceutical Journal (Pal. Med. Pharm. J.) SCImago Journal & Country Rank

DOAJ

Directory of Open Access Journals listing

The DOAJ record is useful for readers, librarians, and authors who want a direct open-access directory entry for the journal.

DOAJ
Palestinian Medical and Pharmaceutical Journal (Pal. Med. Pharm. J.) Open directory record
Original full research article

Stability Indicating Validated Novel RP-HPLC Method for Dexlansoprazole and LC-MS/MS Study of Degradation Product

Published
2024-03-01
Pages
81 - 106
Full text

Keywords

  • Validation
  • Stability Indicating
  • Dexlansoprazole
  • LC-MS/MS.
  • HPLC

Abstract

This work effectively developed and validated a stability-indicating RP-HPLC technique for precisely measuring dexlansoprazole in bulk samples. An Acetonitrile and 0.5 mmol Ammonium Acetate (pH 4.5) gradient mobile phase, a 1 ml/min flow rate, and detection at 283 nm were all part of the method's unique chromatographic conditions. A Kromasil C18 column was also used. Dexlansoprazole had a 5.14-minute retention period, and the tech-nique showed a linear range of 5–30 mg/ml with a strong correlation value of 0.997. The technique showed high sensitivity with a limit of detection (LOD) of 1.2 mg/ml and a limit of quantification (LOQ) of 3.64 mg/ml. The accuracy of the approach was shown by the per-centage recovery of dexlansoprazole, which varied from 98.6% to 102%. The International Council for Harmonisation (ICH) gave standards for validating the created approach, which were followed. It covered several variables: linearity, LOD, LOQ, accuracy, precision, ro-bustness, and solution stability. The technique demonstrated stability and the capacity to successfully separate the degradation products from the analyte peaks, establishing its validi-ty as a stability-indicating technique. LC-MS/MS spectra were also used to establish the degradants' structures.The quantitative measurement of dexlansoprazole in bulk form may be accomplished effectively using this established RP-HPLC technique. It is a useful instru-ment for quality control and stability evaluation of dexlansoprazole in pharmaceutical for-mulations because of its accuracy, precision, and stability-indicating capabilities.

Article history

Received
2023-04-29
Accepted
2023-06-03
Available online
2024-03-01
بحث أصيل كامل

Stability Indicating Validated Novel RP-HPLC Method for Dexlansoprazole and LC-MS/MS Study of Degradation Product

Published
2024-03-01
الصفحات
81 - 106
البحث كاملا

الكلمات الإفتتاحية

  • Validation
  • Stability Indicating
  • Dexlansoprazole
  • LC-MS/MS.
  • HPLC

الملخص

This work effectively developed and validated a stability-indicating RP-HPLC technique for precisely measuring dexlansoprazole in bulk samples. An Acetonitrile and 0.5 mmol Ammonium Acetate (pH 4.5) gradient mobile phase, a 1 ml/min flow rate, and detection at 283 nm were all part of the method's unique chromatographic conditions. A Kromasil C18 column was also used. Dexlansoprazole had a 5.14-minute retention period, and the tech-nique showed a linear range of 5–30 mg/ml with a strong correlation value of 0.997. The technique showed high sensitivity with a limit of detection (LOD) of 1.2 mg/ml and a limit of quantification (LOQ) of 3.64 mg/ml. The accuracy of the approach was shown by the per-centage recovery of dexlansoprazole, which varied from 98.6% to 102%. The International Council for Harmonisation (ICH) gave standards for validating the created approach, which were followed. It covered several variables: linearity, LOD, LOQ, accuracy, precision, ro-bustness, and solution stability. The technique demonstrated stability and the capacity to successfully separate the degradation products from the analyte peaks, establishing its validi-ty as a stability-indicating technique. LC-MS/MS spectra were also used to establish the degradants' structures.The quantitative measurement of dexlansoprazole in bulk form may be accomplished effectively using this established RP-HPLC technique. It is a useful instru-ment for quality control and stability evaluation of dexlansoprazole in pharmaceutical for-mulations because of its accuracy, precision, and stability-indicating capabilities.

Article history

تاريخ التسليم
2023-04-29
تاريخ القبول
2023-06-03
Available online
2024-03-01