Abstract
The presented work describes the method development of simultaneous determination of camylofin dihydrochloride (CMF), diclofenac potassium (DCF), and Paracetamol (PCM) using reversed phase high performance liquid chromatography (HPLC-UV) and the method was further transferred to a new generation instrument, ultraperformance liquid chromatography (UPLC-PDA). The detailed validation was carried out for the combination tablet formulation of CMF and DCF by UPLC-PDA. From the method development study, Acquity UPLC HSS C18 (2.1 × 50 mm, 1.8 μm) was finally selected for validation. The satisfactory results were observed for peak shape, retention time, and resolution with a mobile phase of 20 mM ammonium acetate buffer (pH 3.0 with dilute orthophosphoric acid) : methanol (33 : 67 v/v). The isocratic elution of mobile phase was carried out at a flow rate of 0.250 mL/min and detection at 220 nm. Both drugs were efficiently separated out in less than 3.5 min with 1.1 and 3.2 min of retention time of the CMF and DCF with 11.87 of resolution. The linearity was obtained in the 20.0–80.0 μg/mL range of concentration with 0.9998 of correlation coefficients for the substances. The method was analyzed for specificity with detailed force degradation study, which is a simple, precise, and accurate method, as per the International Conference on Harmonization (ICH) guidelines.
Highlights
Camylofin dihydrochloride (CMF) is an antimuscarinic drug which is used as an antispasmodic drug
Working standards of CMF and Diclofenac potassium (DCF) were purchased from Sigma Aldrich and Paracetamol was gifted by Hetero drugs Limited (Hyderabad, India) and combination tablet of CMF-DCF, Anaspas tablet (CMF 50 mg : DCF 50 mg), and Anafortan (CMF 25 mg : PCM 300 mg) was purchased from the market
The mobile phase was used as diluents in same ratio of 50 : 50 mL v/v which gives better peak shape with good symmetry, resolution, and retention time in validation as well as for stress degradation study
Summary
Camylofin dihydrochloride (CMF) is an antimuscarinic drug which is used as an antispasmodic drug It is known as a 3-methylbutyl 2-(2-diethyl-aminoethylamino)2-phenyl-acetate hydrochloride [1, 2]. Paracetamol (PCM) is chemically known as an N-(4-hydroxyphenyl) acetamide [8] and very well known as an acetaminophen [9]. It is an analgesic and antipyretic class of drug, used for the treatment of fever and pain [10, 11].
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