{'fraction_non_alphanumeric': 0.02745995423340961, 'fraction_numerical': 0.02288329519450801, 'mean_word_length': 4.831111111111111, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 0, 'word_list_counts': {'cursed_substrings.json': 1, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Development and Validation of LC-MS method for the determination of Heptaethylene glycol monomethyl ether in Benzonatate bulk drugs.

A simple and isocratic reverse-phase liquid chromatography with mass spectrometric method has been developed and validated for the determination of Heptaethylene glycol monomethyl ether in Benzonatate drug substance. Benzonatate is an oral antitussive drug used to relieve and suppress cough in patients older than ten years of age. The presence of residual Heptaethylene glycol monomethyl ether in Benzonatate drug substance shall affect the safety, strength, purity, and quality of the drug substance. The subject compound separation was achieved using 0.1% formic acid and acetonitrile (50:50 v/v) at a flow rate of 0.3 mL min-1. The SUPLEX PKB-100 250 X 4.6 mm, 5 μm LC column, was used for better peak shape. Detection was carried out at m/z value of 341. The linearity curve was shown a correlation of coefficient more than 0.999. The precision and intermediate precision % RSD were found less than 7.30. The accuracy values were found more than 90% for all levels. The developed method validated as per International conference on harmonization (ICH) guidelines and found to be a novel, specific and sensitive analytical method of determination of component of interest.