Development and Validation of Stability Indicating High-Performance Liquid Chromatographic Method for Determination of Cyproheptadine Hydrochloride, its Impurity And Degradation Product

Abstract

This work presents a sensitive, accurate and selective RP-HPLC method for simultaneous determination of cyproheptadine HCl (CPH), its impurity B (dibenzosuberone) and CPH oxidative degradation product (10,11-dihydroxy-dibenzosuberone) in bulk powder and in pharmaceutical formulation. The RP-HPLC method depends on isocratic elution using C8 column and mobile phase consisting of 0.05 M KH2PO4 buffer:methanol (35:65, v/v, pH = 4.5) at a flow rate of 2 mL/min, and the eluant was monitored at 245 nm. Good resolution was obtained with tR values of 3.05, 7.54 and 6.17 min for CPH, impurity and oxidative degradate, respectively. The proposed method has been validated as per ICH guidelines using pure forms of CPH, its impurity and degradation product in pharmaceutical formulation with an accuracy of 100.48, 100.16 and 100.11, respectively. Additional spiking experiments yielded an accuracy of 100 ± 1.6%. Repeatability and intermediate precision results indicated acceptable low <2% RSD values. Moreover, the developed method’s statistical results were favorably compared to the previously reported method results regarding both accuracy and precision. The developed method can be applied for analysis of the three components in quality control laboratories.

Simultaneous determination of 10 first‐generation histamine h1 receptor blockers in feeds by ultra‐high‐performance liquid chromatography triple quadrupole ion trap hybrid mass spectrometer

“…There are a few differences in the structure and properties of FHRB. According to the literature, the extraction mainly includes boric acid buffer [17], methanol [28], ethyl acetate [26], the mixed solution of dichloromethane+methanol+diethylamine aqueous solution [22] or methanol+ACN for plasma [19], ACN for feeds [18], Mclivain's buffer for dosage forms [23], and so on. Therefore, methanol, ACN, dichloromethane, ethyl acetate, boric acid buffer, and Mclivain's buffer were selected for optimization of extracting solution.…”

“…Many methods including GC [13,14], collision energy (CE) [15][16][17][18], lC [19][20][21][22][23], and LC-MS [24][25][26][27][28][29][30] have been developed for the determination of histamine H1 receptor blockers in diverse matrix types such as drug carrier, plasma, urine, and animal tissue. However, there are few methods for histamine H1 receptor blockers in feeds [19][20][21][22][23]. Compared to these matrices, feeds contain a large number of interfering substances such as protein, fat, and metal, which makes its matrix more complex, and the content of histamine H1 receptor blockers in feeds is lower than other additives, the use of the inappropriate method will cause matrix interference and infeasible results; in addition, most articles about histamine H1 receptor blockers analysis only focuses on 1-4 analysts, and there is no literature to determine up to 10 histamine H1 receptor blockers.…”

“…Many methods including GC [13,14], collision energy (CE) [15][16][17][18], lC [19][20][21][22][23], and LC-MS [24][25][26][27][28][29][30] have been developed for the determination of histamine H1 receptor blockers in diverse matrix types such as drug carrier, plasma, urine, and animal tissue. However, there are few methods for histamine H1 receptor blockers in feeds [19][20][21][22][23].…”

A novel compounded cyproheptadine hydrochloride oral solution: Accelerated stability study and effects on glucose and lipid metabolism in Wistar rats

“…This also justifies its interest as an appetite stimulant, especially in cases of cystic fibrosis [1,6,7]. This drug is also indicated for treatment of allergic conditions such as urticaria, angioedema, rhinitis, conjunctivitis, and pruritic skin disorders [8][9][10]. Another alternative is combination therapy with tricholine citrate, which is prescribed for hepatobiliary conditions linked with anorexia, leading to weight reduction [11].…”

Validation of Lc-MS/MS Method for Determination of Cyproheptadine in Dietary Supplements

“…The major reported side effects of CP are increased appetite and weight gain, sedation and sleepiness [1]. The literature survey revealed some methods for CP determination in pure form and in pharmaceutical formulations such as gas chromtagraphy [2] spectrophotometric [3], HPLC [4] [5] and LC-MS/MS [6].…”