Method development and validation for simultaneous determination of Eletriptan hydrobromide and Itopride hydrochloride from fast dissolving buccal films by using RP-HPLC

• Autorzy: Siddique Waqar , Sarfraz Rai Muhammad , Zaman Muhammad , Khan Riffat , Gul Maria , Asghar Farhan , Malik Tangina , Saif Asiya , Shamim Qurat-Ul-Ain , Salawi Ahmad , Alshamrani Meshal , Almoshari Yosif , Sabei Fahad Y.

Identyfikatory

DOI

10.1556/1326.2022.01072

• Języki publikacji: EN

Abstrakty

EN

One of the most effective, rapid, and simple methods reversed-phase high-performance liquid chromatography (RP-HPLC) was used for simultaneous development and validation of Eletriptan hydrobromide (ELE HBR) and Itopride hydrochloride (ITP HCL) in combination. The method was validated based on the regulations of United States Pharmacopeia (USP) and International Conference on Harmonization (ICH) guidelines. Separation of both drugs was achieved within approximately 5 min by using a mobile phase made up of a 70:30 ratio of phosphate buffer and acetonitrile having a flow rate of 1 mL min−1. Furthermore, a comprehensive study was conducted on precision, accuracy, linearity, inter-day, intra-day studies, an assay of formulated films, and stability studies of combined prepared film. Co-efficient of correlation ranged between 0.9993, and 0.9965 for ELE HBR and ITP HCL respectively. The accuracy of the developed method was accurate as drug recoveries in both cases of ITP HCL, and ELE HBR falls between (99.87, 99.96, and 99.84%) to (99.81, 99.12, and 98.44%) respectively having a concentration range of solutions between 10, 30 and 50 μg mL−1 dilution. Films developed by using both drugs in combination were then validated for assay studies, and it was found that substantial results of 99.05%, and 99.87% were found in the case of ITP HCL and ELE HBR respectively. The stability of the solution and mobile phase showed the method's accuracy as the results were 97% for ITP HCL and 99% for ELE HBR. The proposed method developed for simultaneous determination of ITP HCL and ELE HBR was developed and validation and no interaction of any excipient were found.

Słowa kluczowe

EN

buccal films; oral solid dosage form; RP-HPLC; eletriptan hydrobromide; itopride hydrochloride

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2023
• Tom: Vol. 35, no. 4
• Strony: 310--318
• Opis fizyczny: Bibliogr. 65 poz., rys., tab., wykr.

Twórcy

autor

Siddique Waqar

• College of Pharmacy, University of Sargodha, Sargodha, Pakistan
• Department of Pharmacy, University of South Asia, Lahore, Pakistan

autor

Sarfraz Rai Muhammad

• College of Pharmacy, University of Sargodha, Sargodha, Pakistan

autor

Zaman Muhammad

• Faculty of Pharmacy, University of Central Punjab, Lahore, Pakistan

• https://orcid.org/0000-0003-0318-5728

autor

Khan Riffat

• School of Pharmaceutical Sciences, Johar Institute of Professional Studies, Lahore, Pakistan

autor

Gul Maria

• School of Pharmaceutical Sciences, Johar Institute of Professional Studies, Lahore, Pakistan

autor

Asghar Farhan

• School of Pharmaceutical Sciences, Johar Institute of Professional Studies, Lahore, Pakistan

autor

Malik Tangina

• Department of Pharmacy, Akhtar Saeed Medical and Dental College Lahore, Pakistan

autor

Saif Asiya

• Faculty of Pharmacy, Bahauddin Zakariya University, Multan, Pakistan

autor

Shamim Qurat-Ul-Ain

• Faculty of Pharmacy, University of Central Punjab, Lahore, Pakistan

autor

Salawi Ahmad

• Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, 45142, Saudi Arabia

autor

Alshamrani Meshal

• Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, 45142, Saudi Arabia

autor

Almoshari Yosif

• Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, 45142, Saudi Arabia

autor

Sabei Fahad Y.

• Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, 45142, Saudi Arabia

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